An Open-label, Non-randomised, Fixed-sequence, Two Period, Phase I Trial to Evaluate the Effect of Different Doses of BI 456906 (Survodutide) on the Single Dose Pharmacokinetics of Bupropion, Caffeine and Midazolam on Otherwise Healthy Volunteers With Overweight or Obesity

This study is open to adults with overweight or obesity who are otherwise healthy. People can join the study if they have a body mass index of 27 to 39.9 kg/m2 and a body weight over 70 kg. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of bupropion, caffeine, and midazolam in the blood.
The study has 2 treatment periods. In Period 1, participants take 1 dose each of midazolam, caffeine, and bupropion as tablets or oral solution on separate days. In Period 2, participants get BI 456906 as an injection under the skin once a week. At 2 selected timepoints in Period 2, participants also take midazolam, caffeine and bupropion as tablets or oral solution on separate days.
Participants are in the study for about 13 months. They visit the study site up to 45 times. At 3 of those visits, participants stay for 5 or 6 days at the study site. During the visits, doctors collect information about participants' health and take blood samples from the participants. They compare the amounts of midazolam, caffeine, and bupropion in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.

Start Date05 Sep 2024

Sponsor / Collaborator

Boehringer Ingelheim GmbH

CTR20242091 / Active, not recruitingPhase 1

Survodutide多次皮下注射剂量递增给药在BMI 24.0-40.0 kg/m2的中国超重或肥胖受试者中的安全性、耐受性和药代动力学研究（非随机化、开放性、平行分组设计）

[Translation] Safety, tolerability and pharmacokinetics of survodutide in Chinese overweight or obese subjects with BMI 24.0-40.0 kg/m2 after multiple subcutaneous injections of ascending doses (non-randomized, open-label, parallel-group design)

研究BMI为24-40.0 kg/m2的中国受试者以递增剂量形式，每周注射Survodutide一次，连续30周后的安全性、耐受性和药代动力学（PK）。

[Translation]

The study investigated the safety, tolerability and pharmacokinetics (PK) of survodutide in Chinese subjects with a BMI of 24-40.0 kg/m2, after 30 weeks of weekly injections in ascending doses.

Start Date12 Aug 2024

Sponsor / Collaborator

Boehringer Ingelheim (China) Investment Co., Ltd.

NCT06492135 / Active, not recruitingPhase 1

Safety, Tolerability and Pharmacokinetics Study of Multiple Rising Subcutaneous Doses of Survodutide in Chinese Participants With Overweight or Obesity (BMI 24.0 to 40.0 kg/m2) (Non-randomization, Open Label, Parallel Group Design)

This study is open to Chinese adults aged 18 to 60 with overweight or obesity. People can join the study if they have a Body Mass Index from 24 to 40.0 kg/m2.
Survodutide is a medicine being developed to help people with overweight or obesity. The purpose of this study is to find out how different doses of survodutide are taken up in the body. Other goals are to test if participants can tolerate different doses of survodutide and whether survodutide helps people with overweight or obesity.
Participants receive survodutide as an injection under the skin once a week for 7.5 months. During this time, participants visit the study site 33 times. 4 of the visits require a stay in the hospital. At the visits, doctors take blood samples to measure the levels of survodutide in participants' blood. The doctors also check participants' health and take note of any unwanted effects.

Start Date15 Jul 2024

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 Oct 2024·Current diabetes reviews

Future is Brighter: New Potential Paradigm-Shifting Medications and Regimens for Diabetes and Obesity

Review

Author: Aliter, Hashem F. ; Al-Horani, Rami A. ; Aliter, Kholoud F.

Abstract::

Diabetes is a chronic illness that can become debilitating owing to its microvascular and macrovascular complications. Its prevalence is increasing and so is its cost. Diabetes, particularly type 2, appears to have a very close relationship with obesity. While lifestyle modifications, exercises, and current therapeutics have substantially improved clinical outcomes, the need for new therapeutics and regimens continue to exist. Several new medications and regimens for diabetes, obesity, and diabesity are showing promising results in advanced clinical trials. For type 1 diabetes mellitus (T1DM), they include teplizumab, ustekinumab, jakinibs, and cell therapies, whereas for type 2 diabetes mellitus (T2DM), they include once-weakly insulin, tirzepatide, high oral dose of semaglutide, orforglipron, retatrutide, CagriSema, and survodutide. Given their structural and mechanistic diversity as well as their substantial efficacy and safety profiles, these medications and regimens are paradigm shifting and promise a brighter future. They will likely enable better disease prevention and management. This review will provide details about each of the above strategies to keep the scientific community up to date about progress in the fields of diabetes and obesity

25 Jul 2024·NEW ENGLAND JOURNAL OF MEDICINE

A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis

Article

Author: Ratziu, Vlad ; Hosseini-Tabatabaei, Azadeh ; Schattenberg, Jörn M ; Alkhouri, Naim ; Lawitz, Eric ; Fraessdorf, Mandy ; Newsome, Philip N ; Noureddin, Mazen ; Neff, Guy W ; Bugianesi, Elisabetta ; Sanyal, Arun J ; Younes, Ramy ; Bedossa, Pierre ; Hussain, Samina Ajaz ; Anstee, Quentin M

BACKGROUND:

Dual agonism of glucagon receptor and glucagon-like peptide-1 (GLP-1) receptor may be more effective than GLP-1 receptor agonism alone for treating metabolic dysfunction-associated steatohepatitis (MASH). The efficacy and safety of survodutide (a dual agonist of glucagon receptor and GLP-1 receptor) in persons with MASH and liver fibrosis are unclear.

METHODS:

In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo. The trial had two phases: a 24-week rapid-dose-escalation phase, followed by a 24-week maintenance phase. The primary end point was histologic improvement (reduction) in MASH with no worsening of fibrosis. Secondary end points included a decrease in liver fat content by at least 30% and biopsy-assessed improvement (reduction) in fibrosis by at least one stage.

RESULTS:

A total of 293 randomly assigned participants received at least one dose of survodutide or placebo. Improvement in MASH with no worsening of fibrosis occurred in 47% of the participants in the survodutide 2.4-mg group, 62% of those in the 4.8-mg group, and 43% of those in the 6.0-mg group, as compared with 14% of those in the placebo group (P<0.001 for the quadratic dose-response curve as best-fitting model). A decrease in liver fat content by at least 30% occurred in 63% of the participants in the survodutide 2.4-mg group, 67% of those in the 4.8-mg group, 57% of those in the 6.0-mg group, and 14% of those in the placebo group; improvement in fibrosis by at least one stage occurred in 34%, 36%, 34%, and 22%, respectively. Adverse events that were more frequent with survodutide than with placebo included nausea (66% vs. 23%), diarrhea (49% vs. 23%), and vomiting (41% vs. 4%); serious adverse events occurred in 8% with survodutide and 7% with placebo.

CONCLUSIONS:

Survodutide was superior to placebo with respect to improvement in MASH without worsening of fibrosis, warranting further investigation in phase 3 trials. (Funded by Boehringer Ingelheim; 1404-0043 ClinicalTrials.gov number, NCT04771273; EudraCT number, 2020-002723-11.).

01 Jun 2024·JOURNAL OF HEPATOLOGY

Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis

Article

Author: Schmid, Bernhard ; Noureddin, Mazen ; Fraessdorf, Mandy ; Alkhouri, Naim ; Andrews, Charles P ; Hosseini-Tabatabaei, Azadeh ; Neff, Guy W ; Schattenberg, Jörn M ; Gane, Edward J ; Sanyal, Arun J ; Mazo, Daniel F ; Fenske, Wiebke K ; Lawitz, Eric J ; Younes, Ramy ; Hussain, Samina Ajaz ; Takács, István

BACKGROUND & AIMS:

Survodutide is a glucagon/glucagon-like peptide-1 receptor dual agonist in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). We investigated the pharmacokinetic and safety profile of survodutide in people with cirrhosis.

METHODS:

This multinational, non-randomized, open-label, phase I clinical trial initially evaluated a single subcutaneous dose of survodutide 0.3 mg in people with Child-Pugh class A, B or C cirrhosis and healthy individuals with or without overweight/obesity matched for age, sex, and weight; the primary endpoints were the area under the plasma concentration-time curve from 0 to infinity (AUC_0-∞) and maximal plasma concentration (C_max). Subsequently, people with overweight/obesity with or without cirrhosis (Child-Pugh class A or B) received once-weekly subcutaneous doses escalated from 0.3 mg to 6.0 mg over 24 weeks then maintained for 4 weeks; the primary endpoint was drug-related treatment-emergent adverse events, with MASH/cirrhosis-related endpoints explored.

RESULTS:

In the single-dose cohorts (n = 41), mean AUC_0-∞ and C_max were similar in those with cirrhosis compared with healthy individuals (90% CIs for adjusted geometric mean ratios spanned 1). Drug-related adverse events occurred in 25.0% of healthy individuals and ≤25.0% of those with cirrhosis after single doses, and 82.4% and 87.5%, respectively, of the multiple-dose cohorts (n = 41) over 28 weeks. Liver fat content, liver stiffness, liver volume, body weight, and other hepatic and metabolic disease markers were generally reduced after 28 weeks of survodutide treatment.

CONCLUSIONS:

Survodutide is generally tolerable in people with compensated or decompensated cirrhosis, does not require pharmacokinetic-related dose adjustment, and may improve liver-related non-invasive tests, supporting its investigation for MASH-related cirrhosis.

IMPACT AND IMPLICATIONS:

Survodutide is a glucagon receptor/glucagon-like peptide-1 receptor dual agonist in development for treatment of metabolic dysfunction-associated steatohepatitis (MASH), which causes cirrhosis in ∼20% of cases. This trial delineates the pharmacokinetic and safety profile of survodutide in people with compensated or decompensated cirrhosis, and revealed associated reductions in liver fat content, markers of liver fibrosis and body weight. These findings have potential relevance for people with MASH-including those with decompensated cirrhosis, who are usually excluded from clinical trials of investigational drugs. Based on this study, further investigation of survodutide for MASH-related cirrhosis is warranted.

CLINICALTRIALS:

GOV IDENTIFIER:

NCT05296733.

News (Medical) associated with Survodutide

30 Sep 2024

·www.prnewswire.com

NeuroBo Pharmaceuticals Announces Positive Top-Line Data From the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity

Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK) Top-Line Data Readout from the MAD Part 2 Expected in the First Quarter of 2025 Planned Phase 1 Part 3 Will Evaluate Early Proof of Concept CAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive top-line safety, tolerability, and dose-linear pharmacokinetics (PK) data from the single ascending dose (SAD) Part 1 of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. In the SAD Part 1 of the Phase 1 clinical trial, a total of 45 obese, otherwise healthy participants were randomized in a double-blind, 6:3 ratio of DA-1726 or placebo. Single ascending doses were found to be safe and well tolerated, with no serious adverse events. Only 5 subjects in the DA-1726 treatment group reported adverse events (AEs) compared with 3 subjects in the placebo group. A dose-linear PK profile was observed across the investigated dose range. Additional cohorts are being added to the SAD Part 1 to explore the maximum tolerated dose. "The safety, tolerability and dose-linear PK data generated from the Part 1 SAD trial are highly encouraging and allowed for the accelerated initiation of our multiple ascending dose (MAD) study," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "In light of the strong safety profile from the SAD Part 1 of the study, we are in the process of adding one or more cohorts to further explore the maximum tolerated dose, which will allow us to realize the full potential of DA-1726. Based on the preclinical data generated to date, as well as DA-1726's balanced activation of GLP1R and glucagon receptors, which increases energy expenditure, we continue to believe that DA-1726 may become a best-in-class obesity drug with a better tolerability profile than currently marketed GLP-1 agonists, and those now in late-stage clinical trials. We eagerly anticipate reporting top-line data from the MAD Part 2 in the first quarter of 2025, which will give us an early read on clinical efficacy. Additionally, we continue to plan Part 3 of the trial that will explore early proof of concept." The MAD Part 2 of the Phase 1 trial is a randomized, placebo-controlled, double-blind study to investigate the safety, tolerability, PK, and PD of multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 2 is expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo. The first patient in the MAD study was dosed ahead of schedule, in late June, as previously reported. The primary endpoint of the Phase 1 trial is to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others. For more information on this clinical trial, please visit: NCT06252220. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. For more information, please visit . Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: NeuroBo Pharmaceuticals Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE NeuroBo Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultLicense out/in

16 Sep 2024

·www.drugs.com

Ozempic Could Curb Progression of Diabetes-Linked Liver Disease

MONDAY, Sept. 16, 2024 -- Fatty liver disease linked to diabetes and obesity can easily progress to liver cirrhosis, but new research suggests that GLP-1 medicines like Ozempic can help stop that. In a new decades-long study, veterans with diabetes and what's known as metabolic dysfunction-associated steatotic liver disease (MASLD) were 14% less likely to progress to cirrhosis if they'd taken a GLP-1, compared to other diabetes meds. One GLP-1 med, semaglutide (Ozempic/Wegovy), seemed especially potent in this regard, according to a team led by Dr. Fasiha Kanwal , a professor of gastroenterology at Baylor College of Medicine in Houston. Overall, the use of GLP-1 meds "was associated with a lower risk of progression to cirrhosis and death," Kanwal's team reported Sept. 16 in the journal JAMA Internal Medicine . They noted that the medicine must be taken early in the course of MASLD: GLP-1s did not help people whose MASLD had already progressed to liver cirrhosis. A healthy liver has a fat content of just 5% or less by weight, but in MASLD fat can rise to unhealthy levels that put people at risk for cirrhosis , liver cancer or even the need for a liver transplant. Obesity and diabetes are prime risk factors driving fatty liver disease. In the new study, the Houston team looked at data from over 32,000 people with diabetes and MASLD who were all cared for at VA hospitals. Participants averaged about 67 years of age. Half had received a GLP-1 drug such as semaglutide (Ozempic), liraglutide ( Saxenda ) or dulaglutide ( Trulicity ) as diabetes treatment, while the other half were in similar health but received another class of diabetes meds, called DPP-4s, instead. Outcomes were tracked from 2006 through to the end of 2022. According to the researchers, GLP-1 use cut a patients' overall odds of progressing to cirrhosis by 14% compared with people taking a DPP-4. The odds of dying during the study period also fell by 11% among GLP-1 users. These healthy effects typically became apparent within 18 to 24 months of using a GLP-1. "The protective association was not seen in patients with existing cirrhosis, underscoring the importance of treatment earlier in the [MASLD] disease course," Kanwal's group said. How are GLP-1s working their magic on the liver? According to the researchers, these drugs "reduce body weight, glycemia [blood sugar issues] and inflammation -- actions that could reduce the risk of MASLD progression." In fact, prior trials have found that GLP-1 meds can even reverse fatty liver disease altogether, Kanwal's team added. At its worst, fatty liver disease and cirrhosis can lead to liver cancer. However, the researchers say the numbers of liver cancer cases in the study was not large enough to determine whether GLP-1s could lower liver cancer risks as well. Newer GLP-1 medications in the pipeline might offer even bigger benefits against MASLD. In late 2023, Eli Lilly reported that its experimental GLP-1 drug, retatrutide, reduced fat in the livers of obese people who took it. And in June, a trial published in the New England Journal of Medicine found that an expermental GLP-1 drug called survodutide also improved liver heath in (83%) of patients with fatty liver disease. That study was funded by the drug's developer, Boehringer Ingelheim. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

09 Sep 2024

·endpts.com

Zealand’s GLP-1/GLP-2 drug bounces back with new Phase 1b data

Zealand Pharma’s GLP-1/GLP-2 receptor dual agonist showed promising weight loss in an early-stage trial after a previous effort with lower doses ended with “underwhelming” efficacy. In part one of the Phase 1b multiple ascending dose trial, Zealand’s dapiglutide achieved a placebo-adjusted mean weight reduction of up to 8.3% at 13 weeks. The study enrolled 54 overweight or obese people with a median baseline BMI of 30.0 kg/m2, according to Monday’s release . The trial didn’t include lifestyle changes such as diet and exercise. Dapiglutide was also well-tolerated with no severe side effects. However, two participants discontinued treatment due to moderate vomiting events and anti-drug antibodies were detected in almost 15% of patients. Part two of the study, which is ongoing, is evaluating higher doses up to 26 mg of dapiglutide over a 28-week period, with a topline readout planned for next year. In the meantime, the part one data “give us the confidence needed to rapidly progress dapiglutide into a comprehensive Phase 2b trial” set to start in the first half of next year, CMO David Kendall said in the release. Back in May, some analysts described dapiglutide as producing “underwhelming” weight loss in a Phase 2a trial that evaluated 4 mg and 6 mg doses of the drug. Doses tested in the Phase 1b are more than twice as high. The company’s “crown jewel” is an amylin analog , petrelintide, that’s set to enter Phase 2b development in overweight and obese people in the second half of the year. Zealand also has a Boehringer Ingelheim-partnered glucagon/GLP-1 receptor dual agonist called survodutide, which the German pharma is testing in a Phase 3 study in obesity.

Clinical ResultPhase 2Phase 1Phase 3

100 Deals associated with Survodutide

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
MASH	Phase 3	US	Boehringer Ingelheim GmbH	13 Mar 2024
MASH	Phase 3	NL	Boehringer Ingelheim GmbH	13 Mar 2024
MASH	Phase 3	ES	Boehringer Ingelheim GmbH	13 Mar 2024
Diabetes Mellitus	Phase 3	US	Boehringer Ingelheim (China) Investment Co., Ltd.	25 Nov 2023
Diabetes Mellitus	Phase 3	JP	Boehringer Ingelheim (China) Investment Co., Ltd.	25 Nov 2023
Diabetes Mellitus	Phase 3	AU	Boehringer Ingelheim (China) Investment Co., Ltd.	25 Nov 2023
Diabetes Mellitus	Phase 3	BE	Boehringer Ingelheim (China) Investment Co., Ltd.	25 Nov 2023
Diabetes Mellitus	Phase 3	CA	Boehringer Ingelheim (China) Investment Co., Ltd.	25 Nov 2023
Diabetes Mellitus	Phase 3	FI	Boehringer Ingelheim (China) Investment Co., Ltd.	25 Nov 2023
Diabetes Mellitus	Phase 3	FR	Boehringer Ingelheim (China) Investment Co., Ltd.	25 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04771273 (1404-0043, Pubmed)	Phase 2	MASH	293	Survodutide 2.4 mg	sxgkwcmhpv(jjnbpagszq) = dpgkqxiolg cuntxxznki (nirxegoxtd ) View more	Positive	07 Jun 2024
				Survodutide 4.8 mg	sxgkwcmhpv(jjnbpagszq) = egcwbbapxx cuntxxznki (nirxegoxtd ) View more
NCT04771273 (Corporate Publications) Manual	Phase 2	MAFLD	295	Survodutide	pccppbnhsz(bnzaribkwq) = hjeagvtsda qgtvqqurkg (uzpyntgowt ) Met	Positive	26 Feb 2024
				placebo	pccppbnhsz(bnzaribkwq) = mblgjuwafp qgtvqqurkg (uzpyntgowt ) Met
NCT04771273 (GlobeNewswire) Manual	Phase 3	MASH	-	survodutide	tdcfehpcvs(bysfgwawob) = rmdtxtgtuh yjdlwwdtbk (bioorckovt ) Met	Positive	26 Feb 2024
				Placebo	tdcfehpcvs(bysfgwawob) = lgrorknbol yjdlwwdtbk (bioorckovt ) Met
NCT04667377 (CTgov)	-	Obesity	387	BI 456906 (0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))	kspnvojpcl(bubsawcdxv) = vccaasfkeb elhiuqxzjg (dftzlgiudy, jboxejzleo - qorjdgnajx) View more	-	02 Nov 2023
				BI 456906 (2.4 mg BI 456906 - Planned Maintenance Treatment)	kspnvojpcl(bubsawcdxv) = zxdjirpcse elhiuqxzjg (dftzlgiudy, bhqzlvjqww - riqefuckbc) View more
NCT04667377 (ADA2023) Manual	Phase 2	Overweight \| Obesity	387	BI 456906 0.6 mg	antabsgmca(ldawpyvpqh) = rvlkuzparf xwnqzfikch (opjqqntbol ) View more	Positive	23 Jun 2023
				BI 456906 2.4 mg	antabsgmca(ldawpyvpqh) = afwtejjhlv xwnqzfikch (opjqqntbol ) View more
NCT04153929 (Phase II, CTgov)	Phase 2	Diabetes Mellitus, Type 2	413	Placebo (Placebo)	qfadmgtqda(bwqegpjfuq) = mmmisnrdsl xygrmwlccn (svfomuhuxz, yvohyqfhrl - asupsizqyc) View more	-	29 Nov 2022
				BI 456906 (BI 456906 0.3 mg)	qfadmgtqda(bwqegpjfuq) = woaznhugqi xygrmwlccn (svfomuhuxz, demvnsyjpf - rjhhdenzjd) View more
EASD2022	Not Applicable	-	-	BI 456906	iudxmdsaif(kusnuotwij) = vehnjeiymc civncyiazw (rvdzkjruwf )	-	22 Sep 2022
				Semaglutide	iudxmdsaif(kusnuotwij) = sperokbgmy civncyiazw (rvdzkjruwf )
NCT04153929 (Phase II, EASD2022)	Phase 2	Diabetes Mellitus, Type 2	411	BI 456906 0.3 mg qw	dqjgcmmnmx(cgkeqohnsv) = rtfychedht icivefwzdi (bqierarxtg )	Positive	21 Sep 2022
				BI 456906 0.9 mg qw	dqjgcmmnmx(cgkeqohnsv) = swisstsrqw icivefwzdi (bqierarxtg )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Survodutide

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation