Roche opens two Phase 3 trials of enicepatide, a dual GLP-1 and GIP drug

Roche has started Phase 3 testing of enicepatide, an experimental drug that acts on two gut hormones, GLP-1 and GIP. The first late-stage study, registered as NCT07351045, is designed to enroll about 2,000 participants and began enrolling around March 16, 2026 ^[1]. A second study, NCT07351058, opened roughly a week later and is listed as evaluating enicepatide in people with obesity or overweight and type 2 diabetes ^[2].

What the two trials are

Both are Phase 3 studies, the stage of testing that usually comes before a company asks the US Food and Drug Administration for approval. The larger one, NCT07351045, targets 2,000 participants ^[1]. The second, NCT07351058, is registered under the drug code RO7795068 and is titled as a study of enicepatide's effects in participants with obesity or overweight and type 2 diabetes ^[2].

Enicepatide came to Roche through its acquisition of Carmot Therapeutics, where it was known as CT-388. It is a dual GLP-1 and GIP agonist, which places it in the same receptor class as tirzepatide (sold as Mounjaro for type 2 diabetes and Zepbound for weight management). Semaglutide (Ozempic, Wegovy and Rybelsus) works on GLP-1 alone.

Neither study has reported results. Details that would matter to a patient reading the registrations — the doses being tested, how long participants are treated, whether each trial compares the drug against a placebo or an already approved medicine, and when the studies are expected to finish — have not been disclosed in the records reviewed.

Why it matters for patients

A Phase 3 program signals that a company believes it has enough early evidence to spend years and thousands of participants testing a drug at scale. For people already using semaglutide or tirzepatide, new entrants in the same broad class could eventually mean more choices, though that depends entirely on results that do not exist yet.

Enicepatide is not approved by the FDA and is not available by prescription. It can currently be obtained only by joining a clinical trial. Trial participants typically receive the study drug or a comparator through the study rather than through a pharmacy, and they are monitored on a schedule set by the protocol; eligibility is determined by each study's inclusion and exclusion criteria.

It is also worth being precise about what a Phase 3 start does and does not mean. Many drugs that reach Phase 3 never reach the market, and results from these two studies — on weight change, blood sugar, side effects, and how the drug compares with existing options — will not be available for some time. Nothing about the launch of these trials changes what is currently prescribed or covered by insurance.

What happens next

Enrollment is the near-term milestone. NCT07351045 began recruiting around March 16, 2026, with a stated target of about 2,000 participants, and NCT07351058 followed about a week later ^[1][2]. Primary completion dates, interim analyses, and any plan to file for FDA approval have not been reported. Roche has not announced when it expects to release data from either study.

For patients who want to follow the program, the two registry entries are the public record of record-keeping changes such as enrollment status, added sites, or revised target numbers. Those updates can shift without any announcement, and a change in a registration is not the same as a result.