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

Last updated: September 2, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Placebo

RO7795081

Clinical Study ID

NCT07081958
BP45702
  • Ages > 18
  • All Genders

Study Summary

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.

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 hypertension, dyslipidemia, diagnosis of obstructive sleep apnea,cardiovascular disease

  • History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

  • A stable body weight for the 3 months prior to screening (maximum 5% body weightgain and/or loss)

Exclusion

Exclusion Criteria:

  • Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes [T1D],T2D, or rare forms of diabetes)

  • Have 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)

  • Participation in unbalanced/extreme diets or in an organized weight reductionprogram within 3 months of the screening visit or planning to engage in such dietsor programs during the study

  • Prior or planned surgical treatment for obesity

  • Have a known, clinically significant gastric emptying abnormality

  • Have poorly controlled hypertension, untreated renal artery stenosis, or evidence oflabile blood pressure including symptomatic postural hypotension

  • 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.

  • Have a history of acute or chronic pancreatitis

  • 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), or had a suicide attempt within the last 1 yearof screening

Study Design

Total Participants: 340
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 29, 2025
Estimated Completion Date:
September 18, 2026

Connect with a study center

  • Pinnacle Research Group

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Pinnacle Research Group

    Anniston 4830198, Alabama 4829764 36207
    United States

    Active - Recruiting

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Asclepes Research Centers

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Orange County Research Center

    Lake Forest 5364514, California 5332921 92630
    United States

    Active - Recruiting

  • Prospective Research Innovations Inc.

    Rancho Cucamonga 5385955, California 5332921 91730
    United States

    Active - Recruiting

  • Asclepes Research Centers

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Active - Recruiting

  • Encompass Clinical Research

    Spring Valley 5398277, California 5332921 91978
    United States

    Active - Recruiting

  • Chase Medical Research

    Waterbury, Connecticut 06708-3346
    United States

    Site Not Available

  • Chase Medical Research

    Waterbury 4845193, Connecticut 4831725 06708-3346
    United States

    Active - Recruiting

  • Emerson Clinical Research Institute LLC

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • Emerson Clinical Research Institute LLC

    Washington D.C. 4140963, District of Columbia 4138106 20009
    United States

    Active - Recruiting

  • K2 Medical Research-Maitland

    Maitland 4163220, Florida 4155751 32751
    United States

    Active - Recruiting

  • K2 Medical Research South Orlando, LLC

    Orlando 4167147, Florida 4155751 32806
    United States

    Active - Recruiting

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City 4227777, Georgia 4197000 30291
    United States

    Active - Recruiting

  • McFarland Clinic under Accellacare

    Ames, Iowa 50010
    United States

    Site Not Available

  • McFarland Clinic under Accellacare

    Ames 4846834, Iowa 4862182 50010
    United States

    Active - Recruiting

  • Mercury Street Medical Group, PLLC

    Butte, Montana 59701
    United States

    Site Not Available

  • Mercury Street Medical Group, PLLC

    Butte 5642934, Montana 5667009 59701
    United States

    Active - Recruiting

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Neurobehavioral Research, Inc.

    Cedarhurst 5111974, New York 5128638 11516
    United States

    Active - Recruiting

  • Accellacare of Cary

    Cary, North Carolina 27518
    United States

    Active - Recruiting

  • Accellacare of Cary - Cary Medical Group

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Accellacare - Hickory

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Accellacare of Raleigh

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Accellacare of Salisbury

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Accellacare of Cary

    Cary 4459467, North Carolina 4482348 27518
    United States

    Active - Recruiting

  • Accellacare of Cary - Cary Medical Group

    Cary 4459467, North Carolina 4482348 27518
    United States

    Active - Recruiting

  • Accellacare - Hickory

    Hickory 4470778, North Carolina 4482348 28601
    United States

    Active - Recruiting

  • Accellacare of Raleigh

    Raleigh 4487042, North Carolina 4482348 27609
    United States

    Active - Recruiting

  • Accellacare of Rocky Mount

    Rocky Mount 4488762, North Carolina 4482348 27804
    United States

    Active - Recruiting

  • Accellacare of Salisbury

    Salisbury 4489985, North Carolina 4482348 28144
    United States

    Active - Recruiting

  • Accellacare of Piedmont Healthcare

    Statesville 4493316, North Carolina 4482348 28625
    United States

    Active - Recruiting

  • Accellacare of Wilmington, LLC

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Active - Recruiting

  • Accellacare Research of Winston Salem

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC (AMR Norman)

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC (AMR Norman)

    Norman 4543762, Oklahoma 4544379 73069
    United States

    Active - Recruiting

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Tristar Clinical Investigations

    Philadelphia 4560349, Pennsylvania 6254927 19114
    United States

    Active - Recruiting

  • Internal Medicine and Pediatrics Associates of Bristol

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Accellacare of Knoxville

    Knoxville, Tennessee 37912
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research. LLC

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Knoxville-Summit-Halls Family Practice

    Knoxville, Tennessee 37938
    United States

    Active - Recruiting

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Internal Medicine and Pediatrics Associates of Bristol

    Bristol 4608657, Tennessee 4662168 37620
    United States

    Active - Recruiting

  • Accellacare of Knoxville

    Knoxville 4634946, Tennessee 4662168 37912
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research. LLC

    Knoxville 4634946, Tennessee 4662168 37909
    United States

    Active - Recruiting

  • Knoxville-Summit-Halls Family Practice

    Knoxville 4634946, Tennessee 4662168 37938
    United States

    Active - Recruiting

  • Clinical Research Associates

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas 78731
    United States

    Site Not Available

  • Apex Mobile Clinical Research

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Juno Research, LLC

    Houston, Texas 77040
    United States

    Site Not Available

  • Consano Clinical Research

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Texas Diabetes & Endocrinology, P.A.

    Austin 4671654, Texas 4736286 78731
    United States

    Active - Recruiting

  • Apex Mobile Clinical Research

    Bellaire 4673353, Texas 4736286 77401
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • Juno Research, LLC

    Houston 4699066, Texas 4736286 77040
    United States

    Active - Recruiting

  • Consano Clinical Research

    Shavano Park 4728147, Texas 4736286 78231
    United States

    Active - Recruiting

  • Chrysalis Clinical Research

    Saint George, Utah 84790
    United States

    Site Not Available

  • Chrysalis Clinical Research

    St. George 5546220, Utah 5549030 84790
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas 4771401, Virginia 6254928 20110
    United States

    Active - Recruiting

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