A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Petrelintide Co-Administered With RO7795068 in Adults With Obesity or Overweight

The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.

Start Date30 Sep 2026

Sponsor / Collaborator

Hoffmann-La Roche Ltd.

[+1]

NCT07843472

/ RecruitingPhase 3

A Phase III, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide Vs. Placebo in Participants With Overweight Or Obesity And Established Cardiovascular Disease

This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and established cardiovascular disease (CVD).

Start Date30 Sep 2026

Sponsor / Collaborator

Hoffmann-La Roche Ltd.

[+1]

NCT07843498

/ RecruitingPhase 3

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide vs. Placebo in Participants With Overweight or Obesity

Start Date30 Sep 2026

Sponsor / Collaborator

Hoffmann-La Roche Ltd.

[+1]

100 Clinical Results associated with Petrelintide

100 Translational Medicine associated with Petrelintide

100 Patents (Medical) associated with Petrelintide

Literatures (Medical) associated with Petrelintide

01 Oct 2026·PHARMACOLOGICAL RESEARCH

Beyond GLP-1: Amylin-based pharmacotherapy and the search for better-tolerated weight-loss drugs

Review

Author: Borner, Tito ; Fischer, Sophia L

Amylin-based pharmacotherapy has re-emerged as a promising strategy for the treatment of obesity and metabolic disease with pharmacological and neural mechanisms distinct from incretin-based therapies. Amylin is a pancreatic β-cell hormone co-secreted with insulin that contributes to postprandial glucose regulation, slows gastric emptying, suppresses glucagon secretion, and promotes satiation through actions in the central nervous system. Recent advances in peptide engineering, lipidation, and reversible albumin binding have enabled the development of long-acting amylin-based agents, including cagrilintide, eloralintide, petrelintide and NN1213. These therapies differ in their pharmacokinetic properties and receptor selectivity, ranging from more selective amylin receptor agonists to dual amylin/calcitonin receptor agonists. This distinction may be critical for understanding both efficacy and tolerability, as calcitonin receptor engagement, exposure kinetics, and downstream neural circuit recruitment may influence whether reduced food intake reflects physiological satiation or aversive signaling. In this review, we summarize the biology of amylin signaling, the historical development of amylin-based therapeutics, and the emerging clinical landscape of long-acting amylin analogs. We place particular emphasis on the tolerability profile of this drug class and discuss how receptor pharmacology, hindbrain and parabrachial circuitry, species differences, and pharmacokinetic exposure may shape nausea, malaise, and emesis. Understanding how amylin-based therapies dissociate weight-loss efficacy from gastrointestinal intolerance may guide the rational design of next-generation anti-obesity drugs with improved clinical utility.

01 Jul 2026·DIABETES OBESITY & METABOLISM

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials

Article

Author: Macura, Stanislava ; Brændholt Olsen, Minna ; Heise, Tim ; Griffin, Jon ; Fredsted Hagen, Berith ; Hesse, Dan ; Hövelmann, Ulrike

ABSTRACT:

Aims:

Petrelintide is a long‐acting amylin analogue in development for weight management. The safety, tolerability, pharmacokinetics, and pharmacodynamics of petrelintide were evaluated in single ascending dose (SAD) and multiple ascending dose (MAD) trials.

Materials and Methods:

Both trials were randomized, placebo‐controlled, and double‐blind. The SAD trial assessed subcutaneous (SC) petrelintide doses of 0.04–2.4 mg and a 0.35 mg intravenous dose. The MAD trial evaluated 6 once‐weekly SC doses of 0.6 and 1.2 mg (part 1), and 16 once‐weekly doses escalated every 2 weeks to target doses of 2.4, 4.8, and 9.0 mg (part 2). The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.

Results:

Petrelintide was well tolerated, with no serious or severe treatment‐emergent adverse events (TEAEs). In both trials, the most common TEAEs included gastrointestinal (GI) disorders, most of which were mild. One participant discontinued treatment due to GI TEAEs. Nausea, the most common GI TEAE, occurred in 16.7%–33.3% of participants receiving petrelintide versus 16.7% for placebo in MAD part 2, while diarrhoea was rare and vomiting was only experienced by the participant who discontinued. Petrelintide was slowly absorbed, had a half‐life of ~10 days, showed steady‐state dose proportionality, and reduced body weight by up to 8.6% after 16 weeks.

Conclusion:

Petrelintide appeared safe, had a low incidence of GI TEAEs, and resulted in clinically relevant weight loss. These findings support further development of petrelintide as an effective weight‐management medication, with potential for improved GI tolerability over existing therapies.

01 Mar 2026·VASCULAR PHARMACOLOGY

Amylin receptors as therapeutic targets in obesity: Emerging peptide-based strategies

Review

Author: Rejili, Mokhtar ; Sahoo, Samir ; Haouala, Faouzi ; Khan, Yumna ; Pal, Amrita ; Arora, Vimal ; Ganesan, Subbulakshmi ; Hussain, Md Sadique

Obesity is a chronic, relapsing metabolic disorder driven by complex genetic and environmental factors, leading to an imbalance in energy regulation. Despite the presence of GLP-1 receptor agonists with induced mild weight loss, there are significant unmet clinical needs with poor efficacy and tolerability problems. Amylin, a neuroendocrine hormone co-released with insulin, controls hunger, gastric motility, glucagon secretion, and energy metabolism via divergent amylin receptor (AMYR) subtypes (1-3), namely the calcitonin receptor (CTR) and the receptor activity-modifying proteins (RAMPs). Novel insight into the molecular make-up of AMYRs and central signaling reinforces its key function in modulating homeostatic and hedonic feeding mechanisms. The article is a review of the emerging preclinical and clinical data regarding the application of peptide-based amylin receptor agonists (AMYRAs), including pramlintide and cagrilintide, KBP-series DACRAs, and investigational drugs, including ZP8396 and amycretin. The agents show enhanced pharmacokinetics, synergy with GLP-1 receptor agonist, and favorable impact on weight regulation and metabolic plasticity. Genetic CALCR and RAMP mutations, new delivery approaches, and dual therapy by digital health technologies and bariatric surgery are also discussed in this review. Of particular interest, amylin-derived medications can have advantages over weight loss but definite disease-modifying action remains to be determined. Taken together, AMYRAs represent a potential category of therapeutics with promising disease-modifying effects that goes beyond weight loss, providing fresh perspectives for precision obesity management by 2030.

117

News (Medical) associated with Petrelintide

01 Oct 2026

·www.biopharmadive.com

3 takeaways from a European obesity scientific meeting

Obesity and metabolic disease specialists are gathering in Milan this week for the annual meeting of the European Association for the Study of Diabetes, one of a few opportunities for drugmakers developing weight-loss treatments to pitch data from experimental drugs to potential future prescribers.As expected, obesity leaders Eli Lilly and Novo made headlines. Still, some fast followers hoped to break through the noise, with Boehringer Ingelheim and AbbVie detailing data from in-licensed assets.As Zepbound and Wegovy continue to rake in billions of dollars a month, the focus is turning to a next generation of treatments that may promise greater weight loss, fewer side effects or more convenience.Eli Lillys amylin-Zepbound comboThe Indianapolis-based drugmaker doesnt appear satisfied with owning a chunk of the obesity market based on the data from its next batch of medicines. Its experimental, triple-acting drug retatrutide impressed investors in May. At EASD, Lilly had data from a different type of three-pronged treatment strategy: Zepbound combined with a separate drug called eloralintide that stimulates a digestive hormone called amylin.The data came from a Phase 2 trialwhich compared the combination to Zepbound or eloralintide alone. The highest doses of the combination taken together over 48 weeks by people with obesity stimulated 23% weight loss, or around 54 pounds, compared with 15% for the high dose of Zepbound and 12%, at the greatest, for eloralintide alone.Based on data seen so far, Leerink Research analyst David Risinger wrote in a client note that he forecasts eloralintide sales of $23 billion in 2035. Eloralintide and other drugs of its type, like Novos cagrilintide and Zealand Pharmas Roche-partnered petrelintide, could emerge as a softer weight-loss option with fewer gastrointestinal side effects, wrote William Blairs Andy Hsieh. Meanwhile, Evercore ISIs Umer Raffat suggested a treatment strategy of starting with more tolerable eloralintide and adding Zepbound if patients want greater weight loss.Novos shot-to-pill dataThe Danish drugmaker is still trying to capitalize on its first-mover advantage in oral GLP-1 treatment by focusing on the promise of transitioning patients from the injectable forms to its Wegovy pill. At EASD, it presented data from a real world study of de-identified patient data it did in conjunction with direct-to-consumer partner Ro.People who switched either from the Wegovy shot or Zepbound to the Wegovy pill and continued for at least another three months lost, on average, an additional 4.1% of their body weight. The proportion of trial participants who were classified as obese fell from 87% to 66%, Novo said.These are exciting early insights on how the pill can individualize obesity care, and we look forward to seeing longer-term outcomes, Louis Aronne, a study investigator and director of the Comprehensive Weight Control Center at Weill Cornell Medicine, said in a statement.New competitors?Boehringer Ingelheim has had a presence in metabolic medicine for years, marketing alongside Lilly a groundbreaking diabetes drug called Jardiance. Its innovation in obesity came via a partnership with Zealand Pharma, licensing a shot called survodutide that targets GLP-1 and glucagon.Data from a study in people with obesity came earlier this year, and at EASD, the privately held German company outlined results from a trial in the more challenging population of those with obesity and diabetes. Enrollees who got survodutide and remained on treatment lost on average 13% of their body weight, significantly more than the 3% lost by those who got a placebo.AbbVie, meanwhile, also has entered the market via a partnership. In its case, it licensed a long-acting amylin-targeting drug it calls ABBV-295 from Gubra for $350 million. The aim is to reduce the frequency of shots to up to monthly intervals.In a small Phase 1 trial detailed at EASD, once-weekly shots stimulated an average weight loss of up to 10% at week 12, while people receiving a shot every other week lost up to 10%. Those getting monthly shots lost 8%, compared with less than 1% for those getting placebo. One-third of people getting the experimental drug experienced nausea, compared with one-fifth of those who got the placebo. '

Clinical ResultPhase 2Phase 1Drug Approval

30 Sep 2026

·firstwordpharma.com

EASD26: New data reveal petrelintide's weight-loss curve flattens after mid-dose

Newly published Phase II obesity study data for Roche and Zealand Pharma's petrelintide reveal previously undisclosed results by dose, with weight loss largely leveling off among the three highest doses.The findings, published in The Lancet Diabetes & Endocrinology and presented at the European Association for the Study of Diabetes (EASD) meeting on Wednesday, show mean weight reductions from baseline to week 28 of 7.9% with both 1 mg and 2.5 mg, 9.8% with 5 mg, 9.3% with 7 mg and 9.4% with 9 mg, compared to 1.7% with placebo.Petrelintide also improved several measures linked to heart and metabolic health, reducing waist circumference by up to 10.8 cm (vs 4.3% with placebo); high-sensitivity C-reactive protein by up to 41% (vs 6% with placebo); and triglycerides by up to 21% (vs 9% with placebo). Pulse rate was lowered by up to 2.9 beats per minute (vs a slight increase with placebo).Filling in the blanksThe results provide additional detail on the ZUPREME-1 trial after Roche and Zealand reported topline data in March, which left investors unimpressed, as well as additional findings in June (see – Vital Signs: AbbVie, Roche face off in amylin updates and Spotlight On ADA: Amylin makes its case to replace GLP-1).At those updates, the partners highlighted up to 10.7% mean weight loss at week 42, but hadn't disclosed the week 28 primary endpoint or results for individual dose cohorts. Roche did say, however, that all five treatment arms of the amylin analogue had shown statistically significant and clinically meaningful weight loss versus placebo at week 28.The Swiss pharma struck a $1.4-billion deal in 2025 to co-develop and co-commerecialise the therapy with Zealand.Petrelintide was given as a once-weekly subcutaneous injection in the 493-person trial, with dose escalation every fourth week. After the 16-week dose-escalation period, the maintenance phase of the study lasted through week 42.The Lancet publication also provides a closer look at the tolerability profile that Roche and Zealand hope can be a potential differentiator for petrelintide over GLP-1–targeting rivals in the obesity space.Nausea was the most common adverse event (AE), occurring in 20% of petrelintide-treated participants versus 6% with placebo, and was predominantly mild and associated with dose escalation. Vomiting occurred in 3% of petrelintide-treated participants versus 6% with placebo, while diarrhoea occurred in 7% of both groups and constipation in 7% versus 4%, respectively.The study authors said a "low proportion" of participants discontinued petrelintide due to gastrointestinal AEs, while a "small percentage" required dose reduction for this reason.Phase III underwayA global Phase III registrational programme with petrelintide monotherapy for chronic weight management is now underway, while a Phase II trial evaluating the combination of petrelintide and Roche's dual GLP-1/GIP receptor agonist enicepatide (CT-388) is expected to start in the second half.Analysts last week said recent Phase II data for enicepatide appeared "competitive" versus similar weight loss drugs.

Phase 2Clinical ResultPhase 3

29 Sep 2026

·www.biospace.com

Roche cuts muscle-sparing obesity drug after mid-stage disappointment

iStock, Andrii Yalanskyi Roche’s anti-myostatin therapy emugrobart is unlikely to elicit meaningful weight loss, according to an interim mid-stage analysis, prompting the pharma to return the asset rights to its subsidiary Chugai Pharmaceutical. Roche will no longer advance an investigational obesity candidate—a move that BMO Capital Markets said “narrows” the pharma’s near-term strategy in the body composition obesity market. Rights for the candidate, called emugrobart, will now revert back to Chugai Pharmaceutical, according to a Monday news release . In March this year, Roche also discontinued development of the anti-myostatin antibody for spinal muscular atrophy (SMA) and facioscapulohumeral muscular dystrophy, citing underwhelming efficacy. In obesity, Roche was testing emugrobart in the Phase 2 GYMINDA trial to assess the efficacy and safety of the asset in combination with Eli Lilly’s approved weight loss blockbuster tirzepatide. The decision to cut emugrobart “narrows Roche’s near-term body-composition strategy,” BMO analysts wrote on Monday. To stand out in the crowded obesity space, the pharma had been working on improving the quality of weight loss by minimizing the loss of lean mass. Emugrobart was designed to achieve this outcome by targeting myostatin, which limits the size and growth of skeletal muscles. Other companies have also worked to disrupt myostatin’s action, including Biohaven with taldefgrobep alfa. Lilly previously tried this path with the antibody bimagrumab, though the pharma in September last year nixed the asset for strategic reasons.“The decision removes Roche’s myostatin-targeting approach from a competitive field and highlights the difficulties of pursuing obesity treatment approaches that are focused on preserving muscle during pharmacologic weight loss,” BMO Capital Markets wrote on Monday. The company, however, pledged to keep going in obesity. “Roche remains committed to advancing quality care for people living with obesity and related comorbidities,” a company spokesperson told BioSpace over email, pointing specifically to the pharma’s recent partnership with Hanmi Pharm to advance a non-incretin peptide therapy. The asset, called HM17321, “represents a potential novel obesity treatment designed to promote weight loss, improve insulin sensitivity and increase muscle mass,” the Roche spokesperson added. With rights to emugrobart under its wing, Chugai plans to resume the asset’s development for SMA, pointing to certain “clinical signals,” as well as the asset’s subcutaneous administration and safety profile, according to the Monday announcement. Chugai is majority owned by Roche but maintains managerial independence and continues to earn from in-house products, which can be used to fund its own drug development. The subsidiary is looking to advance emugrobart into Phase 3, while still considering out-licensing options, according to the Monday announcement. Spinal muscular atrophy Roche Ends Run for Muscular Atrophy Drug, Leaving Door Open for Competitors The main beneficiary of Roche’s discontinuation of an investigational spinal muscular atrophy drug is Scholar Rock, which was hobbled by manufacturing concerns at a Novo Nordisk facility last year but is now nearing a potential resolution. March 20, 2026 · 2 min read · Tristan Manalac Read more Roche’s obesity pipeline is headlined by assets obtained in the $2.7 billion takeover of Carmot Therapeutics in late 2023. Last week, the centerpiece of that deal, enicepatide, cut blood sugar and body weight in patients with type 2 diabetes who are overweight or have obesity. The GLP-1/GIP drug is in two late-stage studies for weight management. Also anchoring Roche’s obesity program is the Zealand Pharma-partnered amylin drug petrelintide. Obesity Myriad catalysts on deck for obesity’s brightest stars as market continues to accelerate Current leaders Eli Lilly and Novo Nordisk have cornered the early market for weight loss therapeutics, but several other players, large and small, are bidding for a piece of the potential $200 billion pie. August 27, 2026 · 6 min read · Michael Gibney Read more

Phase 2Acquisition

100 Deals associated with Petrelintide

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	United States	Hoffmann-La Roche Ltd.	30 Sep 2026
Obesity	Phase 3	United States	Hoffmann-La Roche Ltd.	30 Sep 2026
Overweight	Phase 1	Germany	Zealand Pharma A/S	17 Dec 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05096598 (ADA2026)	Phase 1	Weight Loss	72	Petrelintide	enllsqruwu(unlzyolnuo) = The incidence of gastrointestinal (GI) AEs was low with OW doses; vomiting occurred in one participant, who was also the only participant to discontinue due to GI AE ttyjigexbh (lydvcgcdjg )	Positive	20 Jun 2026
				Placebo
ZUPREME 1 (ADA2026)	Phase 2	Obesity	485	Petrelintide	cdbjirhqpm(jiegkgfgnu) = bumbuhoisg vuewwdohiv (kzcbjegxnb ) View more	Positive	20 Jun 2026
				Placebo	ydisovieto(skpdcybvcl) = fncqiqpamy yfhonqaxaa (ehjmlghvxi )
NCT06662539 (ZUPREME-1, Company pipeline) Manual	Phase 2	Overweight \| Obesity	493	petrelintide	tllemlsyzz(neravsyfbj) = resulted in statistically significant and clinically meaningful weight loss. taviwwmhpl (fcgdlnimpr ) Met View more	Positive	05 Mar 2026
				Placebo
NCT05613387 (MAD, Biospace) Manual	Phase 1	Overweight	48	Petrelintide	jsvuqtjcne(retbkdgtsx) = Petrelintide was assessed to be well tolerated in the trial, with no serious or severe adverse events (AEs). All gastrointestinal (GI) AEs were mild except for two moderate events (nausea and vomiting) reported by one participant who discontinued treatment after the third dose. zcqzcpoypw (dyffczrgxg ) View more	Positive	20 Jun 2024
				Placebo
NCT05613387 (MAD , GlobeNewswire) Manual	Phase 1	Obesity	-	ZP8396 0.6mg (administered once-weekly)	gkxqlgoohh(ztruebzlme) = ldsjoquayr ftayrvqqnn (xbeaczxvpm )	Positive	03 Jul 2023
				ZP8396 1.2mg (administered once-weekly)	gkxqlgoohh(ztruebzlme) = nraxjrijzb ftayrvqqnn (xbeaczxvpm )
NCT05096598 (ADA2023)	Not Applicable	Overweight	56	ZP8396	lrjirrfyif(zwtisejjnn) = most events were mild and transient wslhmzpyvg (tbiqtdcjck ) View more	Positive	20 Jun 2023
				Placebo

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