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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
30
Nanjing Gulou Hospital
Nanjing, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
Incidence, Severity, and Causal Relationship to Treatment of Adverse Events
Time frame: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Clinical Laboratory Test Findings
Time frame: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Vital Signs
Time frame: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Electrocardiogram (ECG) Results
Time frame: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Psychiatry Parameters
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.
Time frame: Baseline to Safety Follow-Up (26 weeks)
Plasma Concentration of RO7795081
Time frame: At prespecified timepoints on Weeks 8, 14, 17, 19, 21, and 22
Maximum Plasma Concentration Observed (Cmax) of RO7795081
Time frame: At prespecified timepoints on Weeks 8, 14, and 22
Time to Cmax (Tmax) of RO7795081
Time frame: At prespecified timepoints on Weeks 8, 14, and 22
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081
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Time frame: At prespecified timepoints on Weeks 8, 14, and 22