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ACTIVE NOT RECRUITING
NCT07081958
PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2025-07-29

Completion Date

2026-07-17

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DRUG

RO7795081

RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.

DRUG

Placebo

Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.

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

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Accellacare of Duly Health and Care

Oak Lawn, Illinois, United States

McFarland Clinic under Accellacare

Ames, Iowa, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

Accellacare of Cary

Cary, North Carolina, United States

Accellacare - Hickory

Hickory, North Carolina, United States

Accellacare of Raleigh

Raleigh, North Carolina, United States

Accellacare of Rocky Mount

Rocky Mount, North Carolina, United States

Accellacare of Salisbury

Salisbury, North Carolina, United States

Accellacare of Piedmont Healthcare

Statesville, North Carolina, United States

Accellacare of Wilmington, LLC

Wilmington, North Carolina, United States

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, United States

Alliance for Multispecialty Research, LLC (AMR Norman)

Norman, Oklahoma, United States

Tristar Clinical Investigations

Philadelphia, Pennsylvania, United States

Internal Medicine and Pediatrics Associates of Bristol

Bristol, Tennessee, United States

Alliance for Multispecialty Research. LLC

Knoxville, Tennessee, United States

Accellacare of Knoxville

Knoxville, Tennessee, United States

Knoxville-Summit-Halls Family Practice

Knoxville, Tennessee, United States

Clinical Research Associates

Nashville, Tennessee, United States

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Apex Mobile Clinical Research

Bellaire, Texas, United States

Velocity Clinical Research

Dallas, Texas, United States

Juno Research, LLC

Houston, Texas, United States

Consano Clinical Research

Shavano Park, Texas, United States

Chrysalis Clinical Research

St. George, Utah, United States

Manassas Clinical Research Center

Manassas, Virginia, United States