A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight Without Type 2 Diabetes

Last updated: April 6, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

RO7795068

Placebo

Clinical Study ID

NCT07351045
WC45725
2025-523104-71-00
  • 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Eligibility Criteria

Inclusion

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 sleepapnea, 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 injectionfrom a trained individual if visually impaired or with physical limitations)

Exclusion

Exclusion Criteria:

  • History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis orhyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetesis 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) 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)

  • History of acute or chronic pancreatitis or clinically significant gallbladderdisease. History of acute pancreatitis caused by gallstones or clinicallysignificant gallbladder disease is allowed if the participant had a cholecystectomyto 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 ischemicattack; Unstable angina; Hospitalization due to congestive heart failure.

  • Have a history of significant active or unstable major depressive disorder (MDD) orother severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or otherserious mood or anxiety disorder). Participants with MDD or generalized anxietydisorder whose disease state is considered stable within 1 year prior to screeningand expected to remain stable throughout the course of the study, in the opinion ofthe investigator, are allowed provided that they are not receiving prohibitedmedication.

  • 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: 2000
Treatment Group(s): 2
Primary Treatment: RO7795068
Phase: 3
Study Start date:
March 16, 2026
Estimated Completion Date:
August 28, 2028

Connect with a study center

  • Paratus Clinical Western Sydney

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Wharton Medical Clinic

    Hamilton, Ontario L8L 5G8
    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

  • 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

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Pinnacle Research Group

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Arizona Clinical Trials

    Tucson, Arizona 85711
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research, LLC

    San Diego, California 92123
    United States

    Active - Recruiting

  • Elevate Clinical Research

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Monroe Biomedical Research

    Louisville, Kentucky 40213
    United States

    Active - Recruiting

  • International Diabetes Center At Park Nicollet

    Minneapolis, Minnesota 55416
    United States

    Active - Recruiting

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Headlands Reseach- Summit

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Trial Management Associates

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Elevate Clinical

    Houston, Texas 77058
    United States

    Active - Recruiting

  • Elevate Clinical

    McAllen, Texas 78504
    United States

    Active - Recruiting

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