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

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Conditions

ObesityOverweightOverweight 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:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status: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 CriteriaExclusion Criteria
  1. * BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-related comorbidities are not required for inclusion)
  2. * 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
  3. * History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight
  4. * Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11 pounds \[lbs\]) within 3 months prior to screening
  1. * Prior history or diagnosis of DM
  2. * Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema
  3. * Have obesity induced by other endocrinologic disorders
  4. * Participation in unbalanced/extreme diets
  5. * Prior or planned surgical treatment for obesity
  6. * Endoscopic and/or device-based therapy for obesity or device removal within 6 months prior to screening
  7. * Have a known clinically significant gastric emptying abnormality
  8. * 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)
  9. * 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
  10. * Have evidence of a significant, uncontrolled endocrine abnormality
  11. * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy
  12. * Have evidence of a significant, active autoimmune abnormality
  13. * Have anemia
  14. * Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease
  15. * Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Contacts and Locations

Study Contact

Reference Study ID Number: BC45538 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Juno Research, LLC
Houston, Texas, 77040
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 Date2027-09-30

Study Record Updates

Study Start Date2025-05-05
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Overweight
  • Overweight With One Weight Related Comorbidity