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
| Registry | NCT07499050 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: double, basic science |
| Enrollment | 30 (Estimated) |
| Sponsor | Hoffmann-La Roche (Industry) |
| Conditions | Healthy Volunteers, Overweight or Obesity |
| Interventions | RO7795081, Placebo (Drug) |
| Dates | start 2026-03-30, primary completion 2027-01-09 (estimated), completion 2027-01-09 (estimated), first posted 2026-03-30, last updated 2026-08-10 |
| Locations | 2 sites in China |
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All trials for Healthy Volunteers All trials for Overweight or Obesity All trials of RO7795081 All trials of Placebo
This is 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| RO7795081 | Experimental | Drug: RO7795081 | |
| Placebo | Placebo comparator | Drug: Placebo |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Nanjing Gulou Hospital | Nanjing | China | |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | China |