Pharma Friday – May 1, 2026

An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *

Boehringer Ingelheim’s Novel Glucagon/GLP-1 Dual Agonist Survodutide Shows Promise in Phase 3 Trial

On April 28, Boehringer Ingelheim announced positive topline results from the Phase III SYNCHRONIZE-1 trial, in which survodutide (BI 456906) met the co-primary endpoints using both the efficacy and treatment-regimen estimands. 

Adults living with obesity or overweight, without type 2 diabetes, who were treated with survodutide experienced sustained weight loss of up to an average of 16.6% after 76 weeks using the efficacy estimand, a statistically significant decrease versus 3.2% in the placebo arm (p<0.0001)^.  This level of weight loss supports survodutide’s potential as a clinically meaningful treatment option for people living with obesity or overweight.¹ Full data from the Phase III trial will be presented at the upcoming American Diabetes Association’s (ADA) 2026 Scientific Sessions in June. 

The trial met its other co-primary endpoint, with up to 85.1% of adults treated with survodutide achieving a body weight reduction of ≥5% after 76 weeks of treatment, using the efficacy estimand, versus 38.8% in the placebo arm (p<0.0001). Initial analysis indicates that body weight reduction with survodutide was driven predominantly by loss of fat tissue, with lean mass contributing only a small proportion of total weight. 

In a key secondary endpoint, adults treated with survodutide experienced a statistically significant reduction in waist circumference – a clinical marker closely linked to visceral fat and cardiometabolic risk² – after 76 weeks versus placebo. Excess visceral fat, particularly around the abdomen, is a known contributor to metabolic dysfunction and is closely connected to impaired liver function^. As a dual glucagon/GLP‑1 receptor agonist, survodutide has the potential to address obesity while also supporting liver function, a key regulator of metabolic health. 

Survodutide’s GLP‑1 agonism decreases appetite while increasing fullness and satiety, while its glucagon agonism is thought to directly act on the liver to reduce hepatic fat, regulate metabolic function, resolve inflammation, and improve fibrosis.

As expected with GLP-1-based therapies, participants in the trial experienced gastrointestinal events, with discontinuations happening more frequently during the dose escalation phase. These events were both mild to moderate in severity and temporary, with no new safety concerns observed outside of what is expected for the GLP-1 class. 

Survodutide is an investigational agent and has not been approved for use; its efficacy and safety has not been established. SYNCHRONIZE-1 is part of a comprehensive global Phase III obesity program, evaluating survodutide in people living with overweight and obesity, among key sub-populations.¹⁴ Additional trial results are expected to read out during 2026. Survodutide is also being studied in two global Phase III clinical trials LIVERAGE and LIVERAGE-Cirrhosis investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4).

Survodutide is the first in a broader portfolio of therapies being developed for people living with obesity or obesity and connected metabolic health conditions, with multiple approaches under investigation. This includes an investigational, potential first-in-class triple GLP-1, GIP, NPY2 receptor agonist peptide (BI 3034701), which will be entering Phase II in the middle of 2026, as well as additional experimental approaches including oral treatment options.

Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes Showing C-Peptide Improvement and Durability Following 12-Weeks of Icovamenib Treatment

On April 27, Biomea Fusion, Inc., a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase 2 COVALENT-112 trial evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 1 diabetes. These data are based on a proof-of-concept study enrolling small subsets of Stage 3 type 1 diabetes patients dosed with icovamenib at 100 mg and 200 mg in two cohorts (patients diagnosed within 3 years and those diagnosed within 3-15 years).

“The results we presented today mark an encouraging step forward for Biomea. The magnitude and durability observed are not typically seen in type 1 diabetes, which makes these findings particularly compelling. These data further validate targeting menin as a potential approach across both type 1 and type 2 diabetes,” said Mick Hitchcock, PhD, Interim CEO and Board Member of Biomea Fusion. “We look forward to presenting additional data at an upcoming scientific meeting and advancing our type 1 diabetes program in collaboration with leading clinical centers in the United States”

The COVALENT-112 trial demonstrated encouraging results in patients with type 1 diabetes. In patients diagnosed within 0-3 years, treatment with icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide area under the curve (AUC) at Week 12 (p < 0.001; n=5), representing a magnitude of improvement that is not commonly reported in published studies of type 1 diabetes. Importantly, the effect was durable following only 12 weeks of dosing, mean C-peptide AUC was largely preserved through Week 52, representing approximately a 7% decline from baseline. A dose response was observed, with the 200 mg dose demonstrating greater activity compared to 100 mg. Published natural history data suggest that patients with Stage 3 type 1 diabetes typically experience substantial declines in C-peptide over time, underscoring the significance of preserved C-peptide following only a 12-week dosing period.

In patients with longer-standing disease (3-15 years since diagnosis), C-peptide levels were generally preserved through Week 52 (12-week treatment period + 40-week follow-up), with only a modest decline from baseline.

Icovamenib was generally well tolerated, with no new or unexpected safety signals identified throughout the 52-week observation period. Unlike investigational approaches in type 1 diabetes that rely primarily on immune suppression or cellular transplantation, icovamenib is designed as a short course, orally administered therapy targeting beta cell biology, with effects that appear to persist beyond the treatment period.

Based on these data, Biomea, in collaboration with four U.S. academic centers, is planning a Phase 2 trial in patients with type 1 diabetes diagnosed within the past three years. The study will evaluate whether extended dosing (up to 6 or 12 months) at 200 mg further improves C-peptide and whether the addition of an immunosuppressive agent enhances clinical outcomes. This study is planned to be initiated within the second half of this year at the Barbara Davis Center for Diabetes, Joslin Diabetes Center, University of Texas Health Science Center at San Antonio Diabetes Division, and the University of Miami Diabetes Research Institute.

“Efforts to intervene against type 1 diabetes have historically focused on preserving remaining insulin secretion in people just diagnosed with type 1 diabetes,” said G. Alexander Fleming, MD, Founder & Executive Chairman of Kinexum and former FDA Senior Medical Officer and Division Leader for Metabolic & Endocrine Drugs, involved in the review of landmark diabetes and metabolic therapies including metformin, the first rapid acting insulin analogs, early statins, and PPAR agonists. “These icovamenib data are unique in showing increased C-peptide-reflected insulin secretion in patients with established type 1 diabetes during dosing and persistence of this effect after treatment was stopped. In people with established type 1 diabetes, endogenous insulin secretion progressively declines to very low levels. Any evidence of improvement in endogenous insulin secretion even among a few type 1 diabetes individuals is unprecedented and of immense biologic and clinical significance. These findings warrant rigorous and longer-term evaluation.”

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