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Roche’s Enicepatide Lowers HbA1c and Produces 15.5% Average Weight Loss in Mid‑Stage Diabetes Trial

Roche’s Enicepatide Lowers HbA1c and Produces 15.5% Average Weight Loss in Mid‑Stage Diabetes Trial
FILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland January 30, 2020. REUTERS/Arnd Wiegmann/File Photo

Roche reported that enicepatide, a once‑weekly GLP‑1/GIP agonist, enabled people with type 2 diabetes to lower blood glucose and lose an average 15.5% of body weight in a mid‑stage trial. The highest tested dose (24 mg) produced significant HbA1c reductions at 48 weeks, and about 62% of treated patients reached HbA1c below 5.7% (the non‑diabetic range). Most side effects were gastrointestinal and mild to moderate; approximately 2% discontinued treatment. Roche plans late‑stage glycemic‑control and cardiovascular outcome trials starting in H1 2027.

Swiss drugmaker Roche reported that its experimental, once‑weekly dual-acting obesity drug enicepatide helped overweight or obese patients with type 2 diabetes reduce blood‑glucose levels and lose an average of 15.5% of body weight in a mid‑stage clinical trial.

Key Trial Results

  • Efficacy: Participants receiving the highest tested dose (24 mg) experienced significant reductions in HbA1c at 48 weeks, helping the treatment meet the study's two primary endpoints.
  • Glycemic Control: About 62% of treated patients achieved HbA1c levels below 5.7%, placing them in the non‑diabetic range.
  • Weight Loss: Overall average weight loss in the diabetes trial was 15.5%. In a separate mid‑stage study reported in June, enicepatide produced an average 22.7% weight loss in overweight or obese participants without diabetes.
  • Safety: In the 447‑patient study, roughly 2% of those taking enicepatide discontinued due to adverse events, compared with none in the placebo group. Most side effects were gastrointestinal and described as mild to moderate—consistent with this class of medicines.

Context and Next Steps

Roche is competing with major pharmaceutical companies such as AstraZeneca and Amgen to enter the fast‑growing obesity treatment market and challenge current leaders Eli Lilly and Novo Nordisk. The obesity therapies market is forecast to exceed $100 billion in annual sales within the next decade.

Roche said it plans to initiate late‑stage studies focused on glycemic control and cardiovascular outcomes in the first half of 2027 to further evaluate enicepatide’s long‑term benefits and safety.

Bottom line: Enicepatide shows promising dual benefits—meaningful weight loss and improved glycemic control—in mid‑stage testing, with a tolerability profile similar to other GLP‑1/GIP agonists. Larger, late‑stage trials will be needed to confirm clinical and cardiovascular outcomes.

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Roche’s Enicepatide Lowers HbA1c and Produces 15.5% Average Weight Loss in Mid‑Stage Diabetes Trial - CRBC News