ACTIVE_NOT_RECRUITING

A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity

Conditions

Obesity Overweight Overweight With One Weight Related Comorbidity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period.

Official Title

A Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Assess Efficacy, Safety, and Tolerability of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity

Quick Facts

Study Start:2025-05-05

Study Completion:2027-07-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06965413

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-related comorbidities are not required for inclusion) * BMI ≥ 27.0 kg/m² and \< 30.0 kg/m² with at least one weight-related comorbidity such as: hypertension, dyslipidemia, obstructive sleep apnea and any cardiovascular disease * History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight * Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11 pounds \[lbs\]) within 3 months prior to screening	* Prior history or diagnosis of DM * Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema * Have obesity induced by other endocrinologic disorders * Participation in unbalanced/extreme diets * Prior or planned surgical treatment for obesity * Endoscopic and/or device-based therapy for obesity or device removal within 6 months prior to screening * Have a known clinically significant gastric emptying abnormality * Have any of the following cardiovascular conditions within 6 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF) * Have evidence of significant active, uncontrolled cardiovascular, autoimmune, endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, a neurological or psychiatric condition, or a history of any neuromuscular disorder or autoimmune/inflammatory disorders that may cause muscle wasting or medical condition capable of constituting a risk when taking the study medication or interfering with the interpretation of data, as judged by the investigator at screening * Have evidence of a significant, uncontrolled endocrine abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy * Have evidence of a significant, active autoimmune abnormality * Have anemia * Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease * Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Inclusion Criteria

Exclusion Criteria

* BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-related comorbidities are not required for inclusion)
* BMI ≥ 27.0 kg/m² and \< 30.0 kg/m² with at least one weight-related comorbidity such as: hypertension, dyslipidemia, obstructive sleep apnea and any cardiovascular disease
* History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight
* Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11 pounds \[lbs\]) within 3 months prior to screening

* Prior history or diagnosis of DM
* Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema
* Have obesity induced by other endocrinologic disorders
* Participation in unbalanced/extreme diets
* Prior or planned surgical treatment for obesity
* Endoscopic and/or device-based therapy for obesity or device removal within 6 months prior to screening
* Have a known clinically significant gastric emptying abnormality
* Have any of the following cardiovascular conditions within 6 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF)
* Have evidence of significant active, uncontrolled cardiovascular, autoimmune, endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, a neurological or psychiatric condition, or a history of any neuromuscular disorder or autoimmune/inflammatory disorders that may cause muscle wasting or medical condition capable of constituting a risk when taking the study medication or interfering with the interpretation of data, as judged by the investigator at screening
* Have evidence of a significant, uncontrolled endocrine abnormality
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy
* Have evidence of a significant, active autoimmune abnormality
* Have anemia
* Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Contacts and Locations

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Pinnacle Research Group

Anniston, Alabama, 36207

United States

Encompass Clinical Research

Spring Valley, California, 91978

United States

K2 Medical Research South Orlando, LLC

Orlando, Florida, 32806

United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291

United States

Accellacare of Duly Health and Care

Oak Lawn, Illinois, 60453

United States

Rochester Clinical Research

Rochester, New York, 14609

United States

Accellacare of Salisbury

Salisbury, North Carolina, 28144

United States

Accellacare of Piedmont Healthcare

Statesville, North Carolina, 28625

United States

Accellacare of Wilmington, LLC

Wilmington, North Carolina, 28401

United States

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, 27103

United States

NexGen Research

Lima, Ohio, 45801

United States

Accellacare of Bristol/ Internal Medicine & Pediatrics

Bristol, Tennessee, 37620

United States

Accellacare of Knoxville

Knoxville, Tennessee, 37912

United States

Clinical Research Associates

Nashville, Tennessee, 37203

United States

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78731

United States

Juno Research, LLC

Houston, Texas, 77040

United States

Consano Clinical Research

Shavano Park, Texas, 78231

United States

Velocity Clinical Research (Impact Research Institute)

Waco, Texas, 76710

United States

Manassas Clinical Research Center

Manassas, Virginia, 20110

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-05

Study Completion Date2027-07-24

Study Record Updates

Study Start Date2025-05-05

Study Completion Date2027-07-24

Terms related to this study

Additional Relevant MeSH Terms

Obesity
Overweight
Overweight With One Weight Related Comorbidity