Roche reports positive Phase 2 results for dual GLP-1/GIP agonist enicepatide in type 2 diabetes and obesity

Roche and its US unit Genentech said a Phase 2 trial of enicepatide, an investigational once-weekly injection that activates both the GLP-1 and GIP receptors, met both of its main goals in adults living with type 2 diabetes and overweight or obesity ^[1][3]. The company called the blood sugar results a potential "best-in-disease" profile ^[1].

The trial, called CT-388-104 (NCT06628362), randomly assigned 447 adults to enicepatide or placebo given under the skin once a week for 48 weeks ^[1][3]. The two co-primary endpoints were change from baseline in HbA1c and in body weight at week 48 ^[3]. HbA1c is a blood test that reflects average blood sugar over the past two to three months ^[1].

What the numbers showed

At the highest titrated dose, 24 mg, average HbA1c fell 2.65% from a starting level of 8.1% ^[1][3]. Among people who entered the study with poorer control — a baseline HbA1c above 8.5% — the average drop at 24 mg was 4.13% ^[1].

By week 48, 90% of people in the 24 mg group had an HbA1c of 6.5% or lower, which is the threshold used to diagnose type 2 diabetes, and 62% reached what the company called normoglycemia, an HbA1c below 5.7% ^[1][3]. Average weight loss in that group was 15.5%, and Roche said the weight curve had not flattened out by the end of the study ^[1].

On safety, Roche described side effects as consistent with other incretin drugs, mostly mild-to-moderate stomach and gut problems, with no new safety signals ^[1][3]. Discontinuation because of side effects was 2.0% in the enicepatide arms and 0.0% in the placebo arm ^[1][3].

One important limit: Roche released topline numbers only and did not provide specific values for the placebo group ^[2]. That makes it impossible right now to judge how much of the HbA1c and weight change was attributable to the drug itself versus diet, study effects and other factors. Full results have not yet been published or presented at a medical meeting.

Where this fits in the pipeline

Enicepatide, formerly known as CT-388, came to Roche through its $2.7 billion buyout of Carmot Therapeutics in 2023 ^[2]. The molecule is described as a "dually biased" GLP-1/GIP agonist, engineered to activate both receptors with little or no ß-arrestin recruitment, a design intended to slow receptor desensitization and extend how long the drug works ^[1][3].

Roche reported separate Phase 2 data earlier in 2026 from the CT-388-103 study in people with obesity or overweight, showing 22.7% weight loss at 48 weeks without a plateau ^[2]. Analysts at BMO Capital Markets wrote in July that despite those results, Eli Lilly's retatrutide was still likely to remain the preferred high-efficacy weight loss agent, citing roughly 24% weight loss at the same timepoint ^[2].

Why it matters for patients

Enicepatide is not approved anywhere and is not available by prescription. Nothing in this announcement changes what US patients can get today from existing GLP-1 medicines such as semaglutide (Ozempic, Wegovy, Rybelsus) or tirzepatide (Mounjaro, Zepbound).

What the data do signal is that a third large company is pushing hard into the same dual GLP-1/GIP mechanism used by tirzepatide. More approved options over time can mean more choices for people who do not tolerate or do not respond well to current drugs, and competition can eventually affect prices — though neither outcome is guaranteed, and pricing has not been discussed.

The finding that 62% of people at the top dose reached a non-diabetic HbA1c range within a year is notable because type 2 diabetes has long been treated as a permanent, progressive condition ^[1]. But this was a mid-stage trial in 447 people, not a long-term outcomes study, and it has not shown whether the drug prevents heart attacks, strokes, kidney failure or other complications ^[1][3].

What happens next

Two Phase 3 trials in chronic weight management, ENITH-1 and ENITH-2, are already running ^[1][3]. Roche said it plans to start a Phase 3 program in glycemic control and cardiovascular outcomes trials in the first half of 2027 ^[1][3]. The company has also said it is exploring combinations, including with petrelintide, the once-weekly amylin drug it is developing with Zealand Pharma ^[2].

Roche has not disclosed a target filing date with the US Food and Drug Administration, and no timeline for full publication of the CT-388-104 results has been reported.