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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity or Overweight

In brief

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.

Key facts

Study ID

NCT07081958

Run by

Hoffmann-La Roche

People needed

352

Starts

2025-07-29

Expected to finish

2026-07-22

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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-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

Full record on ClinicalTrials.gov

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