A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
- Registration Number
- NCT07081958
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 340
-
Participants must have at screening:
- Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or
- BMI ≥27.0 kg/m^2 and <30.0 kg/m^2 with at least one weight-related comorbidity, such as hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, cardiovascular disease
-
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
-
A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)
- Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes [T1D], T2D, or rare forms of diabetes)
- Have obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptor deficiency or Prader-Willi Syndrome)
- Participation in unbalanced/extreme diets or in an organized weight reduction program within 3 months of the screening visit or planning to engage in such diets or programs during the study
- Prior or planned surgical treatment for obesity
- Have a known, clinically significant gastric emptying abnormality
- Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
- Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
- Have a history of acute or chronic pancreatitis
- Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder), or had a suicide attempt within the last 1 year of screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Placebo Placebo - Arm 2: RO7795081 Dosing Regimen 1 RO7795081 - Arm 3: RO7795081 Dosing Regimen 2 RO7795081 - Arm 4: RO7795081 Dosing Regimen 3 RO7795081 - Arm 5: RO7795081 Dosing Regimen 4 RO7795081 - Arm 6: RO7795081 Dosing Regimen 5 RO7795081 - Arm 7: RO7795081 Dosing Regimen 6 RO7795081 - Arm 8: RO7795081 Dosing Regimen 7 RO7795081 -
- Primary Outcome Measures
Name Time Method Percent Change in Body Weight From Baseline to Week 30 Baseline to Week 30
- Secondary Outcome Measures
Name Time Method Absolute Change in Body Weight (kg) from Baseline to Week 30 Baseline to Week 30 Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30 Baseline and Week 30 Absolute Change in Body Weight (kg) from Baseline to Week 38 Baseline to Week 38 Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38 Baseline and Week 38 Absolute Change in BMI (kg/m^2) from Baseline to Week 30 Baseline to Week 30 Plasma Concentrations of RO7795081 at Prespecified Timepoints Predose on Day 1 and at prespecified timepoints until Week 38 Percent Change in Body Weight From Baseline to Week 38 Baseline to Week 38 Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious AEs (SAEs) 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 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).
Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline to Week 42 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.
Absolute Change in BMI (kg/m^2) from Baseline to Week 38 Baseline to Week 38
Trial Locations
- Locations (11)
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Chase Medical Research
🇺🇸Waterbury, Connecticut, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Accellacare of Cary
🇺🇸Cary, North Carolina, United States
Accellacare of Raleigh
🇺🇸Raleigh, North Carolina, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
Juno Research, LLC
🇺🇸Houston, Texas, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
Tristar Clinical Investigations
🇺🇸Philadelphia, Pennsylvania, United States
Scroll for more (1 remaining)Pinnacle Research Group🇺🇸Anniston, Alabama, United States