Active, not recruitingPhase 1Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionHealthy Volunteers, Overweight or Obesity
Full registry 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.
Treatments and study arms
RO7795081
Drug
RO7795081 will be administered orally once a day.
Placebo
Drug
Placebo will be administered orally once a day.
Primary outcomes
Incidence, Severity, and Causal Relationship to Treatment of Adverse EventsBaseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Clinical Laboratory Test FindingsBaseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Vital SignsBaseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Electrocardiogram (ECG) ResultsBaseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Psychiatry ParametersBaseline to Safety Follow-Up (26 weeks)Participants with psychiatric abnormalities include those with a Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at any assessment, any suicidal behavior, or any suicidal ideation of Type 4 (active suicidal ideation with some intent to act without a specific plan) or Type 5 (active suicidal ideation with a specific plan and intent) on any Columbia-Suicide Severity Rating Scale (C-SSRS) assessment.
Study locations
2 locations were listed when this page was built. The first 40 are shown.
Nanjing Gulou Hospital🇨🇳 Nanjing, China Ruijin Hospital Shanghai Jiaotong University School of Medicine🇨🇳 Shanghai, China 