Loading clinical trials...

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

ACTIVE_NOT_RECRUITINGPHASE2

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 38 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

NCT07081958•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (37)

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

Key Dates

Start Date

July 29, 2025

Primary Completion Date

April 23, 2026

Completion Date

July 17, 2026

Last Updated

January 15, 2026

Enrollment

340

ESTIMATED participants

Conditions

Obesity or Overweight

Interventions

RO7795081

DRUG

Placebo

DRUG

A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

NCT07255209

Adolescents With Obesity or Overweight With Weight-Related Comorbidities

View study

RECRUITINGPHASE1

Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection

NCT07128888

Obesity or Overweight

View study

ACTIVE_NOT_RECRUITINGPHASE2

A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions