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A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

Purpose

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.

Condition

Obesity or Overweight

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Participants must have at screening: 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or 2. 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)

Exclusion Criteria

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

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Arm 1: Placebo		Drug: Placebo Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.
Experimental Arm 2: RO7795081 Dosing Regimen 1		Drug: RO7795081 RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period. Other names: CT-996 RG6652
Experimental Arm 3: RO7795081 Dosing Regimen 2		Drug: RO7795081 RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period. Other names: CT-996 RG6652
Experimental Arm 4: RO7795081 Dosing Regimen 3		Drug: RO7795081 RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period. Other names: CT-996 RG6652
Experimental Arm 5: RO7795081 Dosing Regimen 4		Drug: RO7795081 RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period. Other names: CT-996 RG6652
Experimental Arm 6: RO7795081 Dosing Regimen 5		Drug: RO7795081 RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period. Other names: CT-996 RG6652
Experimental Arm 7: RO7795081 Dosing Regimen 6		Drug: RO7795081 RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period. Other names: CT-996 RG6652
Experimental Arm 8: RO7795081 Dosing Regimen 7		Drug: RO7795081 RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period. Other names: CT-996 RG6652

Recruiting Locations

More Details

NCT ID: NCT07081958
Status: Active, not recruiting
Sponsor: Hoffmann-La Roche