This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult participants with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
340
Percent Change in Body Weight From Baseline to Week 30
Time frame: Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline to Week 30
Time frame: Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline to Week 38
Time frame: Baseline to Week 38
Percent Change in Body Weight From Baseline to Week 38
Time frame: Baseline to Week 38
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30
Time frame: Baseline and Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38
Time frame: Baseline and Week 38
Absolute Change in BMI (kg/m^2) from Baseline to Week 30
Time frame: Baseline to Week 30
Absolute Change in BMI (kg/m^2) from Baseline to Week 38
Time frame: Baseline to Week 38
Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious AEs (SAEs)
Time frame: From first dose until 28 days after the final dose of study treatment (42 weeks)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from Baseline to Week 42
The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior during the assessment period via a participant-reported questionnaire comprising 2 to 6 questions (yes or no). Affirmative responses count as 1 point, which are then summed to indicate the level of suicide risk on a scale of 0 (no risk) to 6 (high risk).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pinnacle Research Group
Anniston, Alabama, United States
Orange County Research Center
Lake Forest, California, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, United States
Asclepes Research Centers
Sherman Oaks, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Chase Medical Research
Waterbury, Connecticut, United States
Emerson Clinical Research Institute LLC
Washington D.C., District of Columbia, United States
K2 Medical Research-Winter Garden
Clermont, Florida, United States
K2 Medical Research - The Villages
Lady Lake, Florida, United States
K2 Medical Research-Maitland
Maitland, Florida, United States
...and 27 more locations
Time frame: Baseline to Week 42
Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline to Week 42
PHQ-9 is a 9-item patient reported outcome (PRO) used to assess severity of depression. Responses are rated based on the frequency of symptoms on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A PHQ-9 total score ranging from 0 to 27 can be calculated by summing the nine items; a higher score corresponds with more severe depression.
Time frame: Baseline to Week 42
Plasma Concentrations of RO7795081 at Prespecified Timepoints
Time frame: Predose on Day 1 and at prespecified timepoints until Week 38