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A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight Without Type 2 Diabetes
NCT07351045 · Hoffmann-La Roche
In plain English
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Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes
About this study
The purpose of this study is to assess the efficacy and safety of RO7795068, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
Eligibility criteria
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 prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Exclusion Criteria:
* History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* 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)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
* Poorly controlled hypertension at screening
* 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 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). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
Study design
Enrollment target: 2000 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-03-16
Estimated completion: 2028-08-28
Last updated: 2026-04-07
Interventions
Combination Product: PlaceboCombination Product: RO7795068
Primary outcomes
- • Percent (%) Change from Baseline in Body Weight at Week 72 (Baseline through Week 72)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WC45725 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (22)
Pinnacle Research GroupRecruiting
Anniston, Alabama, United States
Arizona Clinical TrialsRecruiting
Tucson, Arizona, United States
Artemis Institute for Clinical Research, LLCRecruiting
San Diego, California, United States
Elevate Clinical ResearchRecruiting
Gurnee, Illinois, United States
Monroe Biomedical ResearchRecruiting
Louisville, Kentucky, United States
International Diabetes Center At Park NicolletRecruiting
Minneapolis, Minnesota, United States
Clinvest Research LLCRecruiting
Springfield, Missouri, United States
Headlands Reseach- SummitRecruiting
Portland, Oregon, United States
Trial Management AssociatesRecruiting
Myrtle Beach, South Carolina, United States
Clinical Research AssociatesRecruiting
Nashville, Tennessee, United States
Elevate ClinicalRecruiting
Houston, Texas, United States
Elevate ClinicalRecruiting
McAllen, Texas, United States
Paratus Clinical Western SydneyRecruiting
Blacktown, New South Wales, Australia
Wharton Medical ClinicRecruiting
Hamilton, Ontario, Canada
Hasegawa Medicine ClinicRecruiting
Hokkaido, Japan
Higashijujo Sakai Diabetes Internal Medicine ClinicRecruiting
Tokyo, Japan
Changhua Christian HospitalRecruiting
Changhua, Taiwan
Chia-Yi Christian HospitalRecruiting
Chiayi City, Taiwan
Chung Shan Medical University HospitalRecruiting
Taichung, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan