ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-07-29
Study Completion:2026-07-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07081958

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have at screening:
  2. 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
  3. 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
  4. * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
  5. * A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)
  1. * Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes \[T1D\], T2D, or rare forms of diabetes)
  2. * 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)
  3. * 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
  4. * Prior or planned surgical treatment for obesity
  5. * Have a known, clinically significant gastric emptying abnormality
  6. * Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
  7. * 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.
  8. * Have a history of acute or chronic pancreatitis
  9. * 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

Contacts and Locations

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Pinnacle Research Group
Anniston, Alabama, 36207
United States
Orange County Research Center
Lake Forest, California, 92630
United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730
United States
Asclepes Research Centers
Sherman Oaks, California, 91403
United States
Encompass Clinical Research
Spring Valley, California, 91978
United States
Chase Medical Research
Waterbury, Connecticut, 06708-3346
United States
Emerson Clinical Research Institute LLC
Washington D.C., District of Columbia, 20009
United States
K2 Medical Research - The Villages
Lady Lake, Florida, 32159
United States
K2 Medical Research-Maitland
Maitland, Florida, 32751
United States
K2 Medical Research South Orlando, LLC
Orlando, Florida, 32806
United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
United States
McFarland Clinic under Accellacare
Ames, Iowa, 50010
United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
United States
Accellacare of Cary - Cary Medical Group
Cary, North Carolina, 27518
United States
Accellacare of Cary
Cary, North Carolina, 27518
United States
Accellacare - Hickory
Hickory, North Carolina, 28601
United States
Accellacare of Raleigh
Raleigh, North Carolina, 27609
United States
Accellacare of Rocky Mount
Rocky Mount, North Carolina, 27804
United States
Accellacare of Salisbury
Salisbury, North Carolina, 28144
United States
Accellacare of Piedmont Healthcare
Statesville, North Carolina, 28625
United States
Accellacare of Wilmington, LLC
Wilmington, North Carolina, 28401
United States
Accellacare Research of Winston Salem
Winston-Salem, North Carolina, 27103
United States
Alliance for Multispecialty Research, LLC (AMR Norman)
Norman, Oklahoma, 73069
United States
Tristar Clinical Investigations
Philadelphia, Pennsylvania, 19114
United States
Internal Medicine and Pediatrics Associates of Bristol
Bristol, Tennessee, 37620
United States
Alliance for Multispecialty Research. LLC
Knoxville, Tennessee, 37909
United States
Accellacare of Knoxville
Knoxville, Tennessee, 37912
United States
Knoxville-Summit-Halls Family Practice
Knoxville, Tennessee, 37938
United States
Clinical Research Associates
Nashville, Tennessee, 37203
United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731
United States
Apex Mobile Clinical Research
Bellaire, Texas, 77401
United States
Velocity Clinical Research
Dallas, Texas, 75230
United States
Juno Research, LLC
Houston, Texas, 77040
United States
Consano Clinical Research
Shavano Park, Texas, 78231
United States
Chrysalis Clinical Research
St. George, Utah, 84790
United States
Manassas Clinical Research Center
Manassas, Virginia, 20110
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-29
Study Completion Date2026-07-17

Study Record Updates

Study Start Date2025-07-29
Study Completion Date2026-07-17

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity or Overweight