About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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/m² at screening
Agreement to adhere to the contraception requirements
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
RO7795081
DrugRO7795081 will be administered orally once a day.
Placebo
DrugPlacebo will be administered orally once a day.
Treatment groups
Trial outcomes
Primary outcomes
Incidence, Severity, and Causal Relationship to Treatment of Adverse Events
Incidence of Abnormal Clinical Laboratory Test Findings
Incidence of Abnormal Vital Signs
Incidence of Abnormal Electrocardiogram (ECG) Results
Secondary outcomes
Plasma Concentration of RO7795081
Maximum Plasma Concentration Observed (Cmax) of RO7795081
Time to Cmax (Tmax) of RO7795081
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081
Sponsors and contacts
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