RegulationBreakthrough Therapy (United States), Fast Track (United States), PRIME (European Union), Breakthrough Therapy (China), Breakthrough Therapy (Taiwan Province)

Structure/Sequence

Sequence Code 27627504

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Sequence Code 1142931835

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Clinical Trials associated with Survodutide

NCT07768813

/ Not yet recruitingPhase 1

Bioequivalence of Survodutide (BI 456906) When Administered Via Pre-filled Syringe (Formulation A) and Vial (Formulation B2) in Male and Female Trial Participants Who Are Healthy or Otherwise Healthy But Overweight/Obese (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product [formulation A]) and in a vial (test product [formulation B2]) in male and female trial participants who are healthy or otherwise healthy with overweight/obesity, following subcutaneous administration.

Start Date01 Sep 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07754461

/ RecruitingPhase 3

A Phase III, Randomised, Double-blind, Parallel-group, 56-week Study, Evaluating the Efficacy and Safety of Survodutide (BI 456906), Compared With Placebo, in Participants With Type 2 Diabetes, as an Adjunct to Diet and Physical Activity Alone or in Combination With Either Oral Antidiabetic Medications or Insulin

This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join.
The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine.
Depending on a person's diabetes treatment, a person will be assigned either to
* Part A: healthy eating and physical activity
* Part B: diabetes tablets (no injection of insulin)
* Part C: injection of insulin (with or without diabetes tablets)
Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment.
Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.

Start Date24 Aug 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

CTIS2025-524135-39-00

/ Not yet recruitingPhase 1

A study in healthy people or otherwise healthy but overweight or obese to compare 2 formulations of survodutide given in different ways, either as a pre-filled syringe or a pen-like injector

Start Date01 Jun 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Survodutide

100 Translational Medicine associated with Survodutide

100 Patents (Medical) associated with Survodutide

Literatures (Medical) associated with Survodutide

01 Aug 2026·DIABETES OBESITY & METABOLISM

Survodutide for the Treatment of Obesity Disease in Japanese Participants: Rationale, Design and Baseline Characteristics of the Phase 3 SYNCHRONIZE ‐ JP Trial

Article

Author: Yamauchi, Toshimasa ; Borowska, Luiza ; Ogawa, Wataru ; Kato, Marie ; Yokote, Koutaro ; Brueckmann, Martina ; Inoue, Takayoshi ; Yan, Shijia ; Takatsuka, Yoji ; Fukushima, Yasushi

ABSTRACT:

Aims:

There is an unmet need for effective pharmacotherapy for obesity disease management in Japan. Survodutide is a novel glucagon receptor/glucagon‐like peptide‐1 receptor (GLP‐1R) dual agonist with the potential to induce greater weight reductions than GLP‐1R mono‐agonists. We report the design and baseline participant characteristics of the SYNCHRONIZE‐JP trial evaluating survodutide in Japanese adults with obesity disease ( ClinicalTrials.gov : NCT06176365).

Materials and Methods:

SYNCHRONIZE‐JP is a 76‐week, randomised, double‐blind, parallel‐group, multi‐centre, phase 3 clinical trial. Eligible participants were aged ≥ 18 years, with BMI ≥ 35 kg/m 2 with ≥ 1 obesity complication or BMI ≥ 27 kg/m 2 with ≥ 2 obesity complications, ≥ 1 self‐reported unsuccessful dietary effort to lose body weight and ≥ 1 obesity complication required to be type 2 diabetes (T2D; capped at 30% enrolment), hypertension or dyslipidaemia. Participants were randomised 1:1:1 to receive once‐weekly survodutide 3.6 or 6.0 mg, or placebo, accompanied by a reduced‐calorie diet and increased physical activity. The primary endpoints are percentage change in body weight and achievement of body weight reduction ≥ 5% from baseline to Week 76. A subset of participants will be assessed for additional endpoints of liver fat content and body composition.

Results:

Of 274 enrolled participants, 24.1% had T2D. The mean age was 53.1 years; 47.8% were female, and mean BMI was 33.2 kg/m 2 . The most frequent complications were dyslipidaemia (81.4%), hypertension (72.6%), hyperuricaemia (30.3%) and metabolic dysfunction‐associated steatotic liver disease (26.6%).

Conclusions:

The results of SYNCHRONIZE‐JP will provide Japan‐specific efficacy, safety and tolerability data for survodutide and inform its potential role in the management of obesity disease.

01 May 2026·Lancet Diabetes & Endocrinology

Beyond weight loss: multisystem benefits of obesity medications

Review

Author: van Rossum, Elisabeth F C ; Savas, Mesut ; Kuckuck, Susanne ; Boon, Mariëtte R

Obesity is increasingly managed with medications as disease-modifying therapies, reflecting its role as a gateway disease driving metabolic, cardiovascular, reproductive, neuropsychiatric, and mechanical conditions. This Review synthesises evidence from randomised controlled trials and high-quality meta-analyses on approved and late-stage investigational obesity medications, including phentermine-topiramate, naltrexone-bupropion, glucagon-like peptide-1 (GLP-1) receptor agonists (eg, liraglutide, semaglutide, subcutaneously and orally), and newer GLP-1 receptor agonist-based agents (eg, tirzepatide, survodutide, mazdutide, retatrutide, cagrilintide-semaglutide, and amycretin). We evaluated the effects of obesity medications across major obesity-related conditions, including type 2 diabetes, metabolic dysfunction-associated steatotic liver disease, chronic kidney disease, heart failure, cardiovascular disease, obstructive sleep apnoea syndrome, polycystic ovary syndrome (recently named polyendocrine metabolic ovarian syndrome), osteoarthritis, muscle mass, depression, quality of life, and food cravings, along with binge-eating disorders, substance use disorders, and neurodegenerative diseases. Overall, GLP-1-based and multiagonist therapies show beneficial effects across these comorbid conditions. While many benefits of obesity medications are mediated by weight loss, accumulating evidence indicates important weight loss-independent effects, particularly with GLP-1 receptor agonist-based therapies. A broader understanding of these pleiotropic effects is essential to inform personalised obesity management and optimise long-term clinical outcomes.

01 May 2026·DRUGS

Metabolic Dysfunction-Associated Steatohepatitis (MASH)-Cirrhosis Clinical Trials: Lessons Learned and Future Directions

Review

Author: Patil, Rashmee ; Noureddin, Mazen ; Dunn, Winston ; Alkhouri, Naim

Metabolic dysfunction-associated steatohepatitis (MASH)-cirrhosis represents a critical and growing global health burden due to its progression to hepatic decompensation, hepatocellular carcinoma (HCC), and liver-related mortality. A growing number of MASH-related HCCs contribute to the increasing need for liver transplantation. Under current regulatory guidance, Phase 3 trials in compensated MASH cirrhosis compare drug versus placebo on time to a composite endpoint for outcomes. Composite endpoints are major adverse liver outcomes (MALO)-hepatic decompensation (ascites requiring treatment, variceal hemorrhage, hepatic encephalopathy, MELD ≥ 15), liver transplantation-and all‑cause mortality. Future trial sample size hinges on the annual event rate and expected effect size. From prior studies, event rates are ~ 3-20% higher with risk features. Progression to large gastroesophageal varices is now an accepted endpoint and will typically add a 3-5% yearly event rate to the baseline MALO event rate. Effect sizes on hard outcomes in metabolic chronic diseases often range from 0.70-0.85. Trials should enroll high‑risk patients (defined as those with clinically significant portal hypertension [CSPH], Child Turcotte Pugh A cirrhosis, and magnetic resonance elastography measurements > 6.5 kPa), plan 3-5 years of follow‑up and enroll using noninvasive criteria. Accelerated approval based on histologic reversal of cirrhosis is potentially possible; the SYMMETRY Phase 2b trial achieved F4 regression within 96 weeks with efruxifermin. Levers to increase regression include an upper limit for liver stiffness measurement(LSM), a platelet threshold (> 110,000/µL), limiting CSPH, and prespecified proportions with FIB‑4 > 3.5 or enhanced liver fibrosis (ELF) > 11.3. Ongoing studies include but are not limited to survodutide, a glucagon/GLP-1 receptor dual agonist targeting metabolic drivers, efruxifermin, an FGF21 analog, and a conditionally approved drug resmetirom, which is a selective thyroid hormone receptor β agonist.

172

News (Medical) associated with Survodutide

13 Aug 2026

·www.fiercebiotech.com

Zealand sells its rights to Takeda’s blood cancer drug for $100M ahead of FDA approval decision

As the FDA mulls whether to approve Takeda and Protagonist Therapeutics’ rusfertide, Zealand Pharma has sold its own rights to the blood cancer drug in return for $100 million. Takeda and Protagonist are expecting a decision from the FDA in the third quarter, based on a phase 3 trial that linked the peptide hepcidin mimetic to a 76.9% response rate in patients with polycythemia vera (PV). Rusfertide mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and red blood cell production. Protagonist has previously touted the drug as a way for PV patients to reduce or even eliminate the need for regular phlebotomy. Takeda paid Protagonist $300 million upfront for rights to the drug candidate in 2024, but Zealand’s history with rusfertide stretches back to 2012, when the Danish biopharma entered a research collaboration with Protagonist to develop disulfide-rich peptides (DRPs). That agreement gave Zealand responsibility for clinical development of any resulting DRPs discovered under the collaboration. The partnership was terminated in 2014, but Zealand retained an economic interest in what would become rusfertide. Now, Copenhagen-based Zealand has agreed to sell its economic interests in the drug to Royalty Pharma for a total of $100 million. This payout will consist of $50 million upfront, with the remaining $50 million due a year later. Even after the deal, Zealand will still be entitled to 0.25% royalties on net global sales of rusfertide above $1.5 billion. For its part, Royalty will gain 0.75% royalties on sales above the same point. Zealand, which described rusfertide as a “non-core asset,” had 14.4 billion Danish kroner ($2.2 billion) in the bank at the end of June. The company said the fresh cash could help fund its strategy to launch five products by 2030. These include obesity plays like the amylin analog petrelintide, which is set to enter phase 3 trials in the coming months, and the Boehringer Ingelheim-partnered glucagon/GLP-1 agonist survodutide, which is already in late-stage development. “This agreement converts a future potential royalty stream into immediate capital that will be redeployed against future growth opportunities in line with our key strategic priorities under our Metabolic Frontier 2030 strategy,” Zealand’s Chief Financial Officer Henriette Wennicke said in an August 12 release. As the world’s largest buyer of biopharma royalties, the agreement with Zealand follows a string of deals this year that has seen Royalty secure a stake in Neurimmune’s AstraZeneca-partnered transthyretin-mediated amyloidosis drug, co-fund Johnson & Johnson’s chronic autoimmune disease asset and support Teva’s vitiligo therapy . Royalty’s relationship with Zealand stretches back to 2018 , when the firm bought a slice of the rights to two diabetes drugs, Soliqua and Adlyxin, which were both developed at Zealand before being licensed to Sanofi. “We are delighted to expand our relationship with Zealand Pharma through a second collaboration, supporting the company as it continues to advance its innovative pipeline of medicines for obesity and metabolic health,” Royalty CEO Pablo Legorreta said. “This transaction underscores Royalty Pharma’s role as a long-term, trusted partner to biopharma companies as they advance important medicines,” Legorreta added in the release. “Furthermore, we believe rusfertide has the potential to become a transformative treatment option for patients with polycythemia vera, and we look forward to its continued progress through regulatory review.”

13 Aug 2026

·www.biospace.com

Zealand Pharma Announces Financial Results for the First Half of 2026

Company announcement – No. 39 / 2026 Zealand Pharma Announces Financial Results for the First Half of 2026 A landmark first half defined by key milestones delivered for leading obesity assets, and a continued momentum building across all fronts of our Metabolic Frontier 2030 strategy. Announced decision to advance petrelintide into Phase 3 trials in H2 2026 following positive Phase 2 results, demonstrating double-digit weight loss with a tolerability pro comparable to placebo, supporting its potential to redefine the weight management experience for people living with obesity or overweight. Boehringer Ingelheim presented positive results from the SYNCHRONIZE TM -1 and SYNCHRONIZE TM -MASLD Phase 3 trials with survodutide, supporting its potential as a differentiated treatment option for people living with obesity or overweight and metabolic dysfunction, with readouts of the remaining key Phase 3 obesity trials expected later in the year. Initiated a Phase 1b clinical trial with ZP9830, a novel Kv1.3 ion channel blocker, in people with psoriasis, marking the first step towards establishing proof-of-concept for ZP9830 with broad potential across autoimmune and inflammatory diseases. Continued active balance sheet management through launch of a USD 200 million share buyback program and USD 100 million royalty monetization of a non-core asset via agreement with Royalty Pharma for rusfertide. Copenhagen, Denmark, August 13, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced the interim report for the six months ended June 30, 2026, and provided a corporate update. A first half of defining moments “In 2026 to date, we have executed with pace and precision across our pipeline,” Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said. “We delivered on the key commitments we set out at the start of the year, while maintaining our sharp focus on the next wave of metabolic health innovation. What stands out this half is not just the depth and breadth of progress, but what it signals about where the field is heading. At ADA 2026, the consensus among key opinion leaders on unmet needs in chronic weight management was clear: tolerability, treatment persistence, and patient experience now define the conversation, and we believe amylin is emerging as the answer. The opportunity in front of us has never been clearer.” Key financial results for H1 2026 DKK million H1-26 H1-25 Revenue 4,525 9,096 Operating expenses, excl. OOI 1 -1,204 -968 Operating expenses 1 -1,204 -1,164 Operating profit 3,321 7,931 Net financial items 292 -157 Profit for the period 3,524 7,238 DKK million Jun-30, 2026 Dec-31, 2025 Cash position 2 14,457 15,109 Notes: 1. Operating expenses consist of R&D, S&M, G&A and Other operating items (OOI). 2. Cash position includes cash, cash equivalents and marketable securities. Q2 2026 Highlights and Recent Developments Obesity Petrelintide, amylin analog. Presented Phase 2 ZUPREME-1 data at the American Diabetes Association’s 2026 Scientific Sessions. Petrelintide demonstrated double-digit weight reduction and a tolerability pro comparable to placebo in people living with overweight or obesity, supporting its potential as a future first-choice therapy for chronic weight management. Petrelintide, amylin analog. Reached a key milestone with the announcement of decision to advance petrelintide monotherapy into Phase 3 registrational trials, planned for initiation later in 2026. Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim presented results from the SYNCHRONIZE TM- 1 Phase 3 trial in people living with overweight or obesity. The trial met its primary endpoints and showed up to 16.6% weight loss with survodutide. The proportion of lean mass loss reflected no more than 11.3% of change in total tissue mass at the highest dose. The lean loss ratio reported in this company announcement has been updated from 10.8% to 11.3% following a recalculation of the dataset. Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim presented positive results from the SYNCHRONIZE TM -MASLD Phase 3 trial in people with overweight or obesity and MASLD with evidence of inflammation and/or fibrosis. The trial met its primary endpoints and showed that 6 out of 10 survodutide-treated participants achieving liver fat normalization. Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim announced expansion of the development program for survodutide with four Phase 3(b) trials initiating in 2026 to address key unmet needs in people living with obesity and real-world care. ZP6590, GIP receptor agonist . Zealand Pharma initiated a first-in-human clinical trial with ZP6590. Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker . Zealand Pharma initiated a Phase 1b trial with efficacy endpoints, investigating ZP9830 in people with psoriasis. The trial was initiated on the back of positive topline results from the single ascending dose (SAD) part of the combined SAD/multiple ascending dose (MAD) Phase 1a clinical trial with ZP9830 announced earlier in the year. Corporate Camilla Sylvest and Iris Löw-Friedrich were elected to the Zealand Pharma Board of Directors, both bringing deep expertise in metabolic health. Two strategically vital additions as the company enters the next phase of scaling into a generational biotech. On May 7, 2026, Zealand Pharma launched a share buy-back program of up to USD 200 million / DKK 1.3 billion. For more information on the share buy-back program, refer to Zealand Pharma Company Announcement No. 13/2026, May 7, 2026. As of August 7, 2026, total accumulated transactions under the program amount to DKK 742 million. Zealand Pharma entered into a USD 100 million royalty purchase and sale agreement with Royalty Pharma for rusfertide. For more information, refer to Zealand Pharma Company Announcement No. 38/2026, August 12, 2026. Continued to attract top talent and experienced leaders, with several senior hires bringing vital experience in metabolic health. This momentum was underscored by Medwatch’s 2026 Image Report, in which Zealand Pharma took the number one spot as the most attractive employer in the Danish Life Science sector. Upcoming events in the second half of 2026 Obesity Petrelintide, amylin analog. In H2 2026, Zealand Pharma and Roche expect to initiate registrational Phase 3 trials with petrelintide monotherapy. Petrelintide, amylin analog. In H2 2026, Zealand Pharma expects to report topline results from the Phase 2 ZUPREME-2 trial in people with overweight or obesity and type 2 diabetes. Petrelintide/enicepatide (CT-388), amylin+GLP-1/GIP fixed-dose combination. Zealand Pharma and Roche expect to initiate the Phase 2 ZYNERGY trial in people with overweight or obesity in H2 2026. Survodutide, glucagon/GLP-1 receptor dual agonist. Results from the Phase 3 SYNCHRONIZE TM -2 trial will be presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD). Results from the SYNCHRONIZE TM -CVOT trial are expected to be reported and presented later in the year. Rare diseases Glepaglutide in SBS. Zealand Pharma expects to complete the EU marketing authorization application review in H2 2026. In parallel, the company is engaging in partnership discussions for future commercialization of glepaglutide for short bowel syndrome (SBS). Dasiglucagon in CHI. In H2 2026, Zealand Pharma expects to resubmit the New Drug Application (NDA) for congenital hyperinsulinism (CHI) to the U.S. FDA. The submission will encompass both the three weeks use of dasiglucagon (Part 1 of the original NDA) as well as the use beyond three weeks (Part 2 of the original NDA). Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker. ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma expects to report topline data from the MAD part of the Phase 1a clinical trial with ZP9830 in H2 2026. Financial guidance for 2026 The financial guidance for collaboration revenue and operating expenses for 2026 is unchanged, and is expected to be DKK 4.5 billion and DKK 2.7-3.3 billion, respectively. DKK billion 2026 Guidance 3 2025 Actual Collaboration revenue 4.5 9.2 Operating expenses, excl. OOI 2.7-3.3 2.1 Notes: 3. Financial guidance based on foreign exchange rates as of August 12, 2026. Conference call today at 2 PM CET / 8 AM ET Zealand Pharma’s management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results through the first half of 2026 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; and Chief Medical Officer, David Kendall. The conference call will be conducted in English. To receive telephone dial-in information and a unique personal access PIN, please register at . The live listen-only audio webcast of the call and accompanying slides presentation will be accessible at . Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand Pharma’s website at . Financial Calendar for 2026 Q3 2026 November 12, 2026 Q4/FY 2026 February 25, 2027 About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at . Forward-looking Statements This company announcement contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development, and commercialization of pharmaceutical products, the timing of the company’s clinical trials and the reporting of data therefrom and the company’s significant events and potential catalysts in 2026 and financial guidance for 2026. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would”, and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Zealand Pharma® is a registered trademark of Zealand Pharma A/S. Contacts Eric Rojas (Investors) Vice President, Head of Investor Relations erojas@zealandpharma.com Neshat Anis Ahmadi (Investors) Manager, Investor Relations neahmadi@zealandpharma.com Rachel James-Owens (Media) Vice President, Corporate Communications & Media Relations Zealand Pharma Email: RJamesOwens@zealandpharma.com Andreas Hylleberg (Media) Director, External Communications Zealand Pharma Email: AHylleberg@zealandpharma.com Amber Fennell, Jessica Hodgson, Sean Leous (Media) ICR Healthcare Email: ZealandPharma@icrhealthcare.com +44 (0) 7739 658 783 Attachment Zealand Pharma H1 2026 Interim Report

Phase 2Phase 3Phase 1Financial StatementClinical Result

16 Jul 2026

·www.biospace.com

Boehringer Ingelheim strengthens obesity pipeline as potential first-in-class triple receptor agonist BI 3034701 enters Phase II development

Boehringer headquarters Boehringer headquarters, Ingelheim, Germany Boehringer Ingelheim announces the start of a Phase II clinical trial evaluating the efficacy and safety of its novel triple receptor agonist, BI 3034701, in people living with obesity and overweight. 1 BI 3034701 is a potential first-in-class GLP-1/GIP/NYP2 receptor agonist designed to address obesity through three pathways, where neuropeptide Y2 (NPY2)-driven central control of hunger, appetite and food intake is complemented by GLP-1/GIP-mediated satiety, weight reduction, and metabolic regulation. 2,3,4 The novel candidate may offer a highly differentiated, complementary therapeutic option within Boehringer Ingelheim's expanding obesity and cardiometabolic portfolio. Ingelheim, Germany – Boehringer Ingelheim today announces the start of a Phase II clinical trial evaluating its investigational triple GLP-1/GIP/NPY2 receptor agonist, BI 3034701, in patients with obesity and overweight. 1 The trial represents a significant milestone for Boehringer’s cardiometabolic and obesity pipeline, which aims to address obesity as a central driver of interconnected cardiovascular, renal and metabolic conditions. 5,6 Obesity is a complex, chronic disease that impacts more than 1 in 8 people worldwide in many different ways, and can have serious long-term consequences. 7,8 Due to the heterogeneity of the disease, different mechanisms are needed to address different patient needs, disease stages, and risk pro 8,9 BI 3034701 is a potential first-in-class triple agonist designed to activate the GLP‑1, GIP, and NPY2 receptors. 1 By engaging these three complementary biological pathways, the molecule aims to address obesity through simultaneously targeting the regulation of body weight and metabolism. 2,3,4 While the impact of GLP-1 and GIP on satiety, weight, and metabolic regulation is well established, 2 NPY2R agonism provides a potentially differentiated mechanism that is still being investigated. Based on scientific literature, activation of the NPY2 receptor modulates central hunger signaling, while its impact on broader eating behavior remains to be fully elucidated. 4 In Phase I studies, BI 3034701 demonstrated a generally favorable safety and tolerability profile, 10 a key factor in advancing the program into its next phase of clinical development. The Phase II study is designed to evaluate the molecule in people living with obesity and overweight, including dose finding and broader clinical evaluation of efficacy and safety. 1 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “The obesity treatment landscape is rapidly expanding, with a need to target a broader variety of therapeutic mechanisms given that obesity is a heterogeneous disease. This approach may better enable healthcare providers to move towards matching the right treatment to the right patient at the right time,” said Dr Ania Jaestreboff MD, PhD, professor at Yale School of Medicine and Director of the Yale Obesity Research Center (Y-Weight). “At Boehringer Ingelheim, we are working towards a future where earlier, multi-pathway intervention leads to long-term outcomes that prevent the progression of interconnected cardiometabolic diseases,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. “In the future, we expect obesity care to become much more differentiated, and with BI 3034701, we aim to go beyond short-term weight loss and address both the biological and behavioral drivers of obesity.” BI 3034701 is part of a broader portfolio of therapies being developed for people living with obesity or obesity and connected metabolic health conditions, which has multiple approaches under investigation, including survodutide, a dual glucagon/GLP-1 agonist. Results from Phase III trials of survodutide were recently presented at American Diabetes Association’s (ADA) 2026 Scientific Sessions. 11 Boehringer Ingelheim’s pipeline across obesity and liver health also includes additional next-generation therapies and experimental approaches including oral treatment options. 12 Notes to Editors About BI 3034701 BI 3034701 was developed in cooperation with Gubra. Boehringer Ingelheim is solely responsible for further development and global commercialization of BI 3034701. About obesity and overweight In 2016, more than 1.9 billion adults lived with overweight — defined as a body mass index (BMI) of 25 or more. 13 Of these, over 650 million were living with obesity — defined as a BMI of 30 or more. 13 More than one billion people around the world are living with obesity today (1 in 8 of us) — and by 2030, that number could be more than double what it was in 2010. 14 Overweight and obesity are complex chronic conditions involving abnormal or excessive fat accumulation that present a risk to a person’s overall health. 8 About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at Boehringer Ingelheim’s Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. References Clinicaltrials.gov. A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight. Available at: . Last accessed: July 2026. Shah M, Vella A. Rev Endocr Metab Disord . 2014;15(3):181-187. Borner T, et al. Diabetes. 2021 Nov;70(11):2545-2553. Yulyaningsih E, et al . Br J Pharmacol. 2011 Jul;163(6):1170-202. Ndumele, C et al. Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association. Circulation. 2023;148(20):1606–1635. doi:10.1161/CIR.0000000000001184. Bannuru, R. Introduction and Methodology: Standards of Care in Overweight and Obesity 2025. BMJ Open Diabetes Research & Care. 2025;13:e004928. doi:10.1136/bmjdrc-2025-004928. World Obesity Federation. World Obesity Atlas 2025. Last accessed July 2026. Bray A, et al . Obes Rev 2017;18:715-723. Singh V, et al . Adv Ther. 2025 Nov;42(11):5341-5364. Boehringer Ingelheim advances next generation triple-agonist peptide for the treatment of obesity into mid-stage development. Available at: . Last accessed July 2026. Boehringer Ingelheim’s survodutide Phase III trial showed targeted 34% visceral and 63% liver fat reduction, while minimizing lean mass loss in pre-specified analysis, supporting improved metabolic health in people living with obesity. Available at: . Last accessed: July 2026. Boehringer Ingelheim’s novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people with obesity or overweight in Phase III trial. Available at: . Last accessed: July 2026. Igbuan, E.A. J. Appl. Health Sci. Med .,.2026.6(3), pp. 64–79. World Heart Federation. Obesity. 2015. Available at: . Last accessed July 2026. Attachment Boehringer headquarters

100 Deals associated with Survodutide

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis, Liver	Phase 3	United States	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	China	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Japan	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Argentina	Boehringer Ingelheim (China) Investment Co., Ltd.	14 Oct 2024
Fibrosis, Liver	Phase 3	Argentina	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Australia	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Austria	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Belgium	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Brazil	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Bulgaria	Boehringer Ingelheim GmbH	14 Oct 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06066515 (SYNCHRONIZE-1, Pubmed \| N Engl J Med)	Phase 3	Obesity	725	Survodutide 3.6 mg	zvarcqcpyl(zwogohkqol) = nleoljsdnw afesjujvjq (njyngkvsyl, -13.6 to -10.8) View more	Positive	07 Jun 2026
				Survodutide 6.0 mg	zvarcqcpyl(zwogohkqol) = mlcauvgocw afesjujvjq (njyngkvsyl, -14.4 to -11.6) View more
NCT04771273 (NASH_TAG2026)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis \| Fibrosis alanine aminotransferase \| liver stiffness measurement \| enhanced liver fibrosis ... View more	295	Survodutide 2.4 mg	kjbqwelloo(dahunrdckm) = cfgbxbihat lkgtqhmaos (hibhlcalsf ) View more	Positive	04 Feb 2026
				Survodutide 4.8 mg	-
NCT04771273 (1404-0043, CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	295	Survodutide (Survodutide 2.4 mg - Planned Maintenance Treatment)	clyzolppow = qdllwdcdsz ddddrntpqz (mzwunxolzw, sghvcdljod - skheuzawgz) View more	-	03 Dec 2024
				Survodutide (Survodutide 4.8 mg - Planned Maintenance Treatment)	clyzolppow = tvnwjfvkow ddddrntpqz (mzwunxolzw, xkdfwwsecd - sijuyfksej) View more
ESC2024	Phase 2	Obesity	387	Survodutide 4.8 mg	ljgfpxcuts(pynpaqdynv) = mrnekiwojq mqcfhvanly (qmncuyydmy )	Positive	01 Sep 2024
NCT04153929 \| NCT04667377 \| NCT03591718 (1665-P, ADA2024)	Phase 1/2	Diabetes Mellitus, Type 2 \| Obesity HbA1c \| insulin sensitivity \| glucose biomarkers ... View more	-	Survodutide	qvmeopdwrj(ygpnodhfez) = 0.4 vs 0.0 izakcfpike (nntpiyqeym ) View more	Positive	14 Jun 2024
				Placebo
NCT04771273 (1404-0043, Pubmed)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	293	Survodutide 2.4 mg	umjmsfhifw(ovraigrtfr) = ddxaswvxmi stwaegdgnq (fhhwkmfkzi ) View more	Positive	07 Jun 2024
				Survodutide 4.8 mg	umjmsfhifw(ovraigrtfr) = xmttpwpssr stwaegdgnq (fhhwkmfkzi ) View more
NCT04667377 (Phase II Trial, ENDO2024)	Phase 2	Overweight \| Obesity	384	Survodutide 4.8 mg	zqgdigyuli(cknlfkbonn) = ffjrchqxls viworlunzw (htudsteixa )	Positive	01 Jun 2024
				Placebo	zqgdigyuli(cknlfkbonn) = qzpiflweby viworlunzw (htudsteixa )
NCT04771273 (Corporate Publications) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	295	Survodutide	poisthanah(emqadxkccf) = fyyujtieqh balhgldaxm (yvhxqdtcjk ) Met	Positive	26 Feb 2024
				placebo	poisthanah(emqadxkccf) = mfjasjyqdv balhgldaxm (yvhxqdtcjk ) Met
NCT04771273 (GlobeNewswire) Manual	Phase 3	Metabolic Dysfunction Associated Steatohepatitis	-	survodutide	sujgrdugmd(prijhhtnwh) = ghseupnzsu zeemnwupbo (oghibbcfdw ) Met	Positive	26 Feb 2024
				Placebo	sujgrdugmd(prijhhtnwh) = iwmlookjar zeemnwupbo (oghibbcfdw ) Met
NCT04667377 (Phase II Trial, CTgov)	Phase 2	Obesity	387	BI 456906 (0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))	hgpjhgovyj(qyfyxnxosp) = wgfvxpqghn fcgaguhrcu (fmbwjcpsxq, 1.07) View more	-	02 Nov 2023
				BI 456906 (2.4 mg BI 456906 - Planned Maintenance Treatment)	hgpjhgovyj(qyfyxnxosp) = wrcrzapabx fcgaguhrcu (fmbwjcpsxq, 1.01) View more

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