RECRUITING

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

Conditions

Quick Navigation

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

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 38 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

Quick Facts

Study Start:2025-07-31

Study Completion:2026-09-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07081958

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
* 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Reference Study ID Number: BP45702 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Tristar Clinical Investigations

Philadelphia, Pennsylvania, 19114

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 Date2025-07-31

Study Completion Date2026-09-18

Study Record Updates

Study Start Date2025-07-31

Study Completion Date2026-09-18

Terms related to this study

Additional Relevant MeSH Terms

Obesity or Overweight