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

NCT07081958 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: BP45702
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 36

Brief 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.

Conditions

Obesity or Overweight

Outcome Measures

Primary Outcomes (1)

• Percent Change in Body Weight From Baseline to Week 30

  Baseline to Week 30

Secondary Outcomes (11)

• Absolute Change in Body Weight (kg) from Baseline to Week 30

  Baseline to Week 30

• Absolute Change in Body Weight (kg) from Baseline to Week 38

  Baseline to Week 38

• Percent Change in Body Weight From Baseline to Week 38

  Baseline to Week 38

• Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30

  Baseline and Week 30

• Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38

  Baseline and Week 38

Study Arms (8)

Arm 1: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Arm 2: RO7795081 Dosing Regimen 1

EXPERIMENTAL

Drug: RO7795081

Arm 3: RO7795081 Dosing Regimen 2

EXPERIMENTAL

Drug: RO7795081

Arm 4: RO7795081 Dosing Regimen 3

EXPERIMENTAL

Drug: RO7795081

Arm 5: RO7795081 Dosing Regimen 4

EXPERIMENTAL

Drug: RO7795081

Arm 6: RO7795081 Dosing Regimen 5

EXPERIMENTAL

Drug: RO7795081

Arm 7: RO7795081 Dosing Regimen 6

EXPERIMENTAL

Drug: RO7795081

Arm 8: RO7795081 Dosing Regimen 7

EXPERIMENTAL

Drug: RO7795081

Interventions

RO7795081 DRUG

RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.

Also known as: CT-996, RG6652

Arm 2: RO7795081 Dosing Regimen 1; Arm 3: RO7795081 Dosing Regimen 2; Arm 4: RO7795081 Dosing Regimen 3; Arm 5: RO7795081 Dosing Regimen 4; Arm 6: RO7795081 Dosing Regimen 5; Arm 7: RO7795081 Dosing Regimen 6; Arm 8: RO7795081 Dosing Regimen 7

Placebo DRUG

Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.

Arm 1: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have at screening:
• Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (36)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Prospective Research Innovations Inc.

Rancho Cucamonga, California, 91730, United States

Location

Asclepes Research Centers

Sherman Oaks, California, 91403, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Chase Medical Research

Waterbury, Connecticut, 06708-3346, United States

Location

Emerson Clinical Research Institute LLC

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

Location

K2 Medical Research-Winter Garden

Clermont, Florida, 34711, United States

Location

K2 Medical Research-Maitland

Maitland, Florida, 32751, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Accellacare of Duly Health and Care

Oak Lawn, Illinois, 60453, United States

Location

McFarland Clinic under Accellacare

Ames, Iowa, 50010, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Accellacare of Cary

Cary, North Carolina, 27518, United States

Location

Accellacare - Hickory

Hickory, North Carolina, 28601, United States

Location

Accellacare of Raleigh

Raleigh, North Carolina, 27609, United States

Location

Accellacare of Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

Accellacare of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Accellacare of Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Accellacare of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, 27103, United States

Location

Alliance for Multispecialty Research, LLC (AMR Norman)

Norman, Oklahoma, 73069, United States

Location

Tristar Clinical Investigations

Philadelphia, Pennsylvania, 19114, United States

Location

Internal Medicine and Pediatrics Associates of Bristol

Bristol, Tennessee, 37620, United States

Location

Alliance for Multispecialty Research. LLC

Knoxville, Tennessee, 37909, United States

Location

Accellacare of Knoxville

Knoxville, Tennessee, 37912, United States

Location

Knoxville-Summit-Halls Family Practice

Knoxville, Tennessee, 37938, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78731, United States

Location

Apex Mobile Clinical Research

Bellaire, Texas, 77401, United States

Location

Velocity Clinical Research

Dallas, Texas, 75230, United States

Location

Juno Research, LLC

Houston, Texas, 77040, United States

Location

Consano Clinical Research

Shavano Park, Texas, 78231, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 24, 2025
• Study Start: July 29, 2025
• Primary Completion: April 28, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (36)