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Phase II: CT-996 in Obesity or Overweight (Study BP45702)

Clinical Trial Overview

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.

Objective

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.

Trial Design

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double (Participant, Investigator)

Primary Endpoints

Percent Change in Body Weight From Baseline to Week 30

Secondary Endpoints

Absolute Change in Body Weight (kg) from Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline to Week 38
Percent Change in Body Weight From Baseline to Week 38
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38
Absolute Change in BMI (kg/m^2) from Baseline to Week 30
Absolute Change in BMI (kg/m^2) from Baseline to Week 38
Incidence of AEs, AESIs, and SAEs
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from Baseline to Week 42
Change in PHQ-9 Scores from Baseline to Week 42
Plasma Concentrations of RO7795081 at Prespecified Timepoints

CT-996

Other names: RG6652
Modality: GLP-1 Receptor Agonist

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Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion Criteria

18 Years and older
Participants must have at screening:
1. 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 (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 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

Enrollment & Resources

Enrollment

For more information on eligibility criteria, view the study or reach out to our team.

Web

ClinicalTrials.gov
Identifier: NCT07081958

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of July 30, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.

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Submit a Request

Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT

AE
adverse events
AESI
Adverse Events of Special Interest
BMI
Body mass index
MDD
major depressive disorder
PHQ-9
Patient Health Questionnaire-9
SAE
serious adverse events
T1D
Type 1 Diabetes
T2D
Type 2 diabetes