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A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes

NCT07351058 · Hoffmann-La Roche
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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 and 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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).
Eligibility criteria
Inclusion Criteria: * Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations) * Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy. * Body mass index (BMI) ≥27.0 kg/m\^2 * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight Exclusion Criteria: * History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening * Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening * At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening * 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) * Poorly controlled hypertension at screening * 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 * 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: 1600 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-03-23
Estimated completion: 2028-08-07
Last updated: 2026-04-14
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: WC45726 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 (28)
Lakeview Clinical ResearchRecruiting
Guntersville, Alabama, United States
Arizona Clinical TrialsRecruiting
Tucson, Arizona, United States
Orange County Research CenterRecruiting
Lake Forest, California, United States
Ark Clinical ResearchRecruiting
Long Beach, California, United States
Catalina Research Institute, LLCRecruiting
Montclair, California, United States
Emerson Clinical Research InstituteRecruiting
Washington D.C., District of Columbia, United States
Progressive Medical ResearchRecruiting
Port Orange, Florida, United States
Elevate Clinical ResearchRecruiting
Lake Charles, Louisiana, United States
Centennial Medical GroupRecruiting
Columbia, Maryland, United States
Centricity Research Morehead City MultispecialityRecruiting
Morehead City, North Carolina, United States
Remington Davis IncRecruiting
Columbus, Ohio, United States
Essential Medical ResearchRecruiting
Tulsa, Oklahoma, United States
Juno Research, LLCRecruiting
Houston, Texas, United States
Era Health ResearchRecruiting
Redmond, Washington, United States
Paratus Clinical Western SydneyRecruiting
Blacktown, New South Wales, Australia
Dr TG Elliott IncRecruiting
Vancouver, British Columbia, Canada
LMC Clinical Research IncRecruiting
Toronto, 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
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Chung Shan Medical University HospitalRecruiting
Taichung, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Division of Endocrinology and Metabolism;Internal MedicineRecruiting
Chiang Mai, Thailand
A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · TrialPath