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

Last updated: April 13, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Obesity

Treatment

RO7795068

Placebo

Clinical Study ID

NCT07351058
WC45726
2025-523106-32-00
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion Criteria:

  • Ability and willingness to self-administer the study drug (or receive an injectionfrom a trained individual if visually impaired or with physical limitations)

  • Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification orother locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratorytest at screening, and on stable oral therapy for at least 3 months prior toscreening (if applicable). T2DM may be treated with diet/exercise alone or any oralanti-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

Exclusion Criteria:

  • History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosisor history of hyperosmolar state/coma within 12 months prior to screening

  • Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemiaunawareness within the 6 months prior to screening

  • At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2non-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) ordiagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptordeficiency or Prader-Willi syndrome)

  • Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty ifperformed more than 1 year prior to screening is allowed.

  • Known clinically significant gastric emptying abnormality (e.g., severegastroparesis or gastric outlet obstruction)

  • Poorly controlled hypertension at screening

  • Have any of the following cardiovascular conditions within 3 months prior toscreening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transientischemic attack; Unstable angina; Hospitalization due to congestive heart failure

  • Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptortriple agonist) within 6 months prior to randomization

Study Design

Total Participants: 1600
Treatment Group(s): 2
Primary Treatment: RO7795068
Phase: 3
Study Start date:
March 23, 2026
Estimated Completion Date:
August 07, 2028

Connect with a study center

  • Paratus Clinical Western Sydney

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Dr TG Elliott Inc

    Vancouver, British Columbia V5Y 3W2
    Canada

    Active - Recruiting

  • LMC Clinical Research Inc

    Toronto, Ontario M4G 3E8
    Canada

    Active - Recruiting

  • Hasegawa Medicine Clinic

    Hokkaido, 066-0032
    Japan

    Active - Recruiting

  • Higashijujo Sakai Diabetes Internal Medicine Clinic

    Tokyo, 114-0001
    Japan

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua, 50006
    Taiwan

    Active - Recruiting

  • Chia-Yi Christian Hospital

    Chiayi City, 600
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Division of Endocrinology and Metabolism;Internal Medicine

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Lakeview Clinical Research

    Guntersville, Alabama 35976
    United States

    Active - Recruiting

  • Arizona Clinical Trials

    Tucson, Arizona 85711
    United States

    Active - Recruiting

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Active - Recruiting

  • Ark Clinical Research

    Long Beach, California 90815
    United States

    Active - Recruiting

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Active - Recruiting

  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia 20009
    United States

    Active - Recruiting

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Elevate Clinical Research

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Centennial Medical Group

    Columbia, Maryland 21045-5840
    United States

    Active - Recruiting

  • Centricity Research Morehead City Multispeciality

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Remington Davis Inc

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Essential Medical Research

    Tulsa, Oklahoma 74137
    United States

    Active - Recruiting

  • Juno Research, LLC

    Houston, Texas 77040
    United States

    Active - Recruiting

  • Era Health Research

    Redmond, Washington 98052
    United States

    Active - Recruiting

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