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 Without Type 2 Diabetes

ClinicalTrials7 Apr 2026·Phase 3● 6/10i

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 Without Type 2 Diabetes

Hoffmann-La Roche

Phase 3 trial testing RO7795068, a dual GLP-1/GIP receptor agonist, versus placebo for weight management in people with obesity or overweight without type 2 diabetes. The study will enroll 2,000 participants over 72 weeks to assess percent change in body weight. Roche is entering the competitive weight loss market currently dominated by Novo Nordisk's Wegovy and Eli Lilly's Zepbound, targeting people without diabetes who represent the largest obesity population. Completion in July 2028 positions this as a potential third major dual-hormone option if successful.

Strategic signal

Roche's entry validates the dual-hormone obesity market but faces a challenging timeline. With Wegovy and Zepbound already approved and oral semaglutide launching for obesity in January 2026, RO7795068 will compete against established brands with 2-4 year head starts by its 2028-2029 potential approval. The trial's focus on people without diabetes targets the broadest obesity population but also the most competitive segment where payers increasingly demand real-world evidence of sustained weight loss and health outcomes beyond clinical trials.

GLP-1Weight lossHoffmann-La Roche

Original Abstract

The purpose of this study is to assess the efficacy and safety of RO7795068, 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity. | Condition(s): Obesity or Overweight | Primary endpoint(s): Percent (%) Change from Baseline in Body Weight at Week 72 | Enrollment: 2,000 (estimated) | Phase: Phase 3 | Sponsor: Hoffmann-La Roche | Expected completion: 2028-07-24 | Status: Recruiting | Last update: 2026-04-07

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