Multiple oral doses of RO7795081 for healthy Chinese adults with overweight or obesity

An Investigator- and Participant-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight

This trial tests whether taking multiple oral doses of RO7795081 is safe and how it acts in the body in otherwise healthy Chinese adults with overweight or obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hoffmann-La Roche (Industry-sponsored)
• Locations: 2 sites (Nanjing and 1 other locations)
• Trial ID: NCT07499050 on ClinicalTrials.gov

What this trial studies

This Phase I, randomized, participant- and investigator-blind, placebo-controlled, parallel-group study gives multiple oral doses of RO7795081 or matching placebo to otherwise healthy Chinese adults with BMI ≥24 kg/m^2. The main goals are to collect safety, tolerability, pharmacokinetic, and pharmacodynamic data after repeated dosing. Eligible participants must be ethnically Chinese, living in mainland China, pass medical screening, and agree to contraception requirements. Study visits are conducted at clinical sites in Nanjing and Shanghai.

Who should consider this trial

Good fit: Ideal candidates are otherwise healthy ethnically Chinese adults living in mainland China with BMI ≥24 kg/m^2 who meet screening labs and contraception requirements.

Not a fit: People with unstable or significant medical conditions (for example uncontrolled diabetes, serious cardiovascular, renal, hepatic, or psychiatric disease), non-Chinese residents, or those who cannot follow contraception rules are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the study could identify a safe oral dose of RO7795081 and support development of a new medication option for people with overweight or obesity.

How similar studies have performed: While other weight‑loss medications have shown benefit in later‑phase trials, RO7795081 is an investigational agent at an early phase and has not yet been proven for obesity.

Eligibility criteria

Inclusion Criteria:

* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* Participants who are ethnically Chinese and living in mainland China
* Body mass index (BMI) ≥24 kg/m\^2 at screening
* Agreement to adhere to the contraception requirements

Exclusion Criteria:

* Any medical condition or disease that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk in the opinion of the Investigator. Such conditions may include clinically significantly impaired endocrine, thyroid, hepatic, respiratory, or renal function for any reason, unstable diabetes mellitus and insulin dependent diabetes mellitus, clinically significant cardiovascular disease, pheochromocytoma, or history of any psychotic mental illness.

Where this trial is running

Nanjing and 1 other locations

• Nanjing Gulou Hospital — Nanjing, China (Recruiting)
• Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Reference Study ID Number: YP46260 https://forpatients.roche.com/

Conditions Healthy Volunteers; Overweight or Obesity