A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

Clinical Trial26 May 2026Phase 3

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

Hoffmann-La Roche

RO7795068, a dual GLP-1/GIP receptor agonist from Roche, is being tested versus placebo for weight management in people with obesity or overweight and type 2 diabetes. Phase 3 trial targets 1,600 participants over 72 weeks in a randomized, double-blind, placebo-controlled design. This positions Roche to compete directly with Eli Lilly's tirzepatide (Mounjaro/Zepbound) in the dual incretin mechanism space across both diabetes and obesity indications. The trial represents Roche's first major entry into the competitive GLP-1 obesity market dominated by Novo Nordisk and Eli Lilly.

Strategic Signal

Roche enters the dual GLP-1/GIP mechanism that Eli Lilly has dominated with tirzepatide since 2022, potentially creating pricing pressure and formulary competition in both diabetes and obesity markets. US payers who have restricted tirzepatide access due to cost may welcome a second dual incretin option to drive rebate negotiations. However, Roche faces a 6-year delay versus tirzepatide's established efficacy profile and market penetration, requiring superior efficacy data or differentiated safety to gain meaningful share.

GLP-1Weight lossType 2 diabetesDrug comparisonsHoffmann-La Roche Eli Lilly

Original Abstract

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM). | Condition(s): Obesity or Overweight; Type 2 Diabetes Mellitus | Primary endpoint(s): Percent (%) Change from Baseline in Body Weight at Week 72 | Enrollment: 1,600 (estimated) | Phase: Phase 3 | Sponsor: Hoffmann-La Roche | Expected completion: 2028-08-07 | Status: Recruiting | Last update: 2026-05-26

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