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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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.