Roche starts Phase 3 for enicepatide

Roche has started enrolling participants in Phase 3 testing of enicepatide, an experimental GLP-1/GIP dual agonist the company picked up through its 2023 purchase of Carmot Therapeutics. The first study, known as Enith1, is registered on ClinicalTrials.gov and aims to recruit roughly 2,000 people, according to the development summary. A second trial, Enith2, opened about a week later and is enrolling participants with obesity or overweight who also have type 2 diabetes, according to its ClinicalTrials.gov listing ^[2].

Enicepatide was formerly known as CT-388 before Roche's acquisition of Carmot Therapeutics folded it into the company's pipeline. Roche's internal code for the drug is RO7795068, the name used in the Enith2 study title ^[2]. Like semaglutide (sold as Ozempic, Wegovy and Rybelsus) and tirzepatide (Mounjaro and Zepbound), enicepatide works by activating gut hormone receptors involved in appetite and blood sugar control, but it targets both the GLP-1 and GIP receptors at once, similar in mechanism to tirzepatide.

The ClinicalTrials.gov registration for Enith1 lists the general eligibility and study design categories used across federally registered trials, but the specific dose levels, treatment duration, and primary outcome measures for enicepatide were not detailed in the material provided ^[1]. The Enith2 listing confirms the study population includes people with obesity or overweight and type 2 diabetes, but does not specify results, since the trial has only just begun enrolling ^[2]. Because both trials are newly opened, no efficacy or safety data are yet available from either study.

Why it matters for patients

A Phase 3 program is the last stage of testing before a company can ask the Food and Drug Administration to approve a drug for sale. Roche's move to start two large trials at once, one of which includes people with type 2 diabetes, suggests the company intends to pursue approval for enicepatide in both weight management and diabetes, mirroring the two-condition approach already used for semaglutide and tirzepatide. For patients now taking or considering GLP-1 medicines, this development does not create any new treatment option today. Enicepatide is not approved by the FDA and will not be available by prescription until trials are completed and reviewed by regulators, a process that typically spans several years.

The fact that enicepatide acts on both GLP-1 and GIP receptors, the same dual mechanism used by tirzepatide, may be of interest to patients who have followed how dual-agonist drugs have compared with single-target ones like semaglutide in other trials. However, the sources provided do not include any comparative efficacy or side-effect data for enicepatide, so it is not yet known how it might compare to existing options once results are available.

What happens next

Enith1 and Enith2 are both in active enrollment, with Enith2 following Enith1 by about a week, according to the development summary. Neither trial's completion date, results timeline, or specific dosing regimen was included in the source material, so those details remain not yet known. Patients and clinicians will likely need to watch for future data releases or regulatory filings from Roche before any conclusions can be drawn about enicepatide's effectiveness or safety profile.