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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 weight gain and/or loss)

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) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptor deficiency or Prader-Willi Syndrome) - Participation in unbalanced/extreme diets or in an organized weight reduction program within 3 months of the screening visit or planning to engage in such diets or 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 of labile blood pressure including symptomatic postural hypotension - 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. - Have a history of acute or chronic pancreatitis - 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), or had a suicide attempt within the last 1 year of screening

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Arm 1: Placebo
  • Drug: Placebo
    Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.
Experimental
Arm 2: RO7795081 Dosing Regimen 1
  • Drug: RO7795081
    RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
    Other names:
    • CT-996
    • RG6652
Experimental
Arm 3: RO7795081 Dosing Regimen 2
  • Drug: RO7795081
    RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
    Other names:
    • CT-996
    • RG6652
Experimental
Arm 4: RO7795081 Dosing Regimen 3
  • Drug: RO7795081
    RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
    Other names:
    • CT-996
    • RG6652
Experimental
Arm 5: RO7795081 Dosing Regimen 4
  • Drug: RO7795081
    RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
    Other names:
    • CT-996
    • RG6652
Experimental
Arm 6: RO7795081 Dosing Regimen 5
  • Drug: RO7795081
    RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
    Other names:
    • CT-996
    • RG6652
Experimental
Arm 7: RO7795081 Dosing Regimen 6
  • Drug: RO7795081
    RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
    Other names:
    • CT-996
    • RG6652
Experimental
Arm 8: RO7795081 Dosing Regimen 7
  • Drug: RO7795081
    RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
    Other names:
    • CT-996
    • RG6652

Recruiting Locations

Pinnacle Research Group
Anniston 4830198, Alabama 4829764 36207

Prospective Research Innovations Inc.
Rancho Cucamonga 5385955, California 5332921 91730

Asclepes Research Centers
Sherman Oaks 5395244, California 5332921 91403

Chase Medical Research
Waterbury 4845193, Connecticut 4831725 06708-3346

Emerson Clinical Research Institute LLC
Washington D.C. 4140963, District of Columbia 4138106 20009

Rophe Adult and Pediatric Medicine/SKYCRNG
Union City 4227777, Georgia 4197000 30291

McFarland Clinic under Accellacare
Ames 4846834, Iowa 4862182 50010

Mercury Street Medical Group, PLLC
Butte 5642934, Montana 5667009 59701

Neurobehavioral Research, Inc.
Cedarhurst 5111974, New York 5128638 11516

Accellacare of Cary - Cary Medical Group
Cary 4459467, North Carolina 4482348 27518

Accellacare of Cary
Cary 4459467, North Carolina 4482348 27518

Accellacare - Hickory
Hickory 4470778, North Carolina 4482348 28601

Accellacare of Raleigh
Raleigh 4487042, North Carolina 4482348 27609

Accellacare of Salisbury
Salisbury 4489985, North Carolina 4482348 28144

Accellacare of Piedmont Healthcare
Statesville 4493316, North Carolina 4482348 28625

Accellacare Research of Winston Salem
Winston-Salem 4499612, North Carolina 4482348 27103

Alliance for Multispecialty Research, LLC (AMR Norman)
Norman 4543762, Oklahoma 4544379 73069

Tristar Clinical Investigations
Philadelphia 4560349, Pennsylvania 6254927 19114

Internal Medicine and Pediatrics Associates of Bristol
Bristol 4608657, Tennessee 4662168 37620

Alliance for Multispecialty Research. LLC
Knoxville 4634946, Tennessee 4662168 37909

Accellacare of Knoxville
Knoxville 4634946, Tennessee 4662168 37912

Knoxville-Summit-Halls Family Practice
Knoxville 4634946, Tennessee 4662168 37938

Clinical Research Associates
Nashville 4644585, Tennessee 4662168 37203

Texas Diabetes & Endocrinology, P.A.
Austin 4671654, Texas 4736286 78731

Apex Mobile Clinical Research
Bellaire 4673353, Texas 4736286 77401

Juno Research, LLC
Houston 4699066, Texas 4736286 77040

Consano Clinical Research
Shavano Park 4728147, Texas 4736286 78231

Chrysalis Clinical Research
St. George 5546220, Utah 5549030 84790

Manassas Clinical Research Center
Manassas 4771401, Virginia 6254928 20110

More Details

NCT ID
NCT07081958
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BP45702 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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