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Phase II: CT-388 in Obesity (CT-388-103)

Clinical Trial Overview

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered for 48 Weeks to Participants with Obesity or Overweight with At Least One Weight-Related Comorbidity

Objective

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.

Trial Design

SC: Subcutaneous

Primary Endpoints

Percent Change in Body Weight from Baseline to Week 48

Secondary Endpoints

Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Absolute Change in Body Weight (kg) from Baseline from Baseline to Week 48
Percent Change in Body Weight from Baseline to Weeks 48 by Obesity Class
Change in Body Mass Index (BMI) from Baseline to Week 48
Change in Waist Circumference from Baseline to Week 48
Change in Hip Circumference from Baseline to Week 48
Change in Waist-to-Hip Ratio from Baseline to Week 48
Change in Waist-to-Height Ratio from Baseline to Week 48
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48
Change in Fasting Plasma Glucose from Baseline to Week 48
Change in Fasting Insulin from Baseline to Week 48
Change in Fasting C-peptide from Baseline to Week 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48
Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48
Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48

HbA1c: Glycated Hemoglobin
HOMA-IR: Homeostasis Model Assessment of Insulin Resistance
QUICKI: Quantitative Insulin Sensitivity Check Index

CT-388

Other names: RG6640
Modality: Biased dual GLP-1/GIP 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

Male or female, 18 to 75 years of age
Body mass index (BMI) ≥30.0 kg/m^2, OR ≥27.0 kg/m^2 and <30.0 kg/m^2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
At least one self-reported unsuccessful effort to lose body weight

Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
Self-reported body weight change of >5 kg within 3 months before randomization
Any unbalanced/extreme diets within 3 months of the screening visit, or plans to be on such diets during the study
Current or recent participation in an organized weight reduction program
Current or recent use of any treatment that promotes weight loss or glucose metabolism
Current or recent use of treatment that may cause weight gain
Prior or planned surgical treatment for obesity
Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
History of chronic pancreatitis or acute pancreatitis within 6 months before screening
Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
History of major depressive disorder within 2 years of screening, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion)
Family or personal history of medullary thyroid carcinoma
Serum calcitonin ≥20 ng/L
Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method

BMI: Body mass index
T1DM: Type 1 Diabetes Mellitus
T2DM: Type 2 diabetes mellitus

Enrollment & Resources

Enrollment

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

Web

ClinicalTrials.gov
Identifier: NCT06525935

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 February 16, 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

BMI
Body mass index
HbA1c
Glycated Hemoglobin
HOMA-IR
Homeostasis Model Assessment of Insulin Resistance
NLM
National Library of Medicine
QUICKI
Quantitative Insulin Sensitivity Check Index
SC
Subcutaneous
SGLT-2
sodium-glucose cotransporter-2
SMBG
Self-Monitored Blood Glucose
T1DM
Type 1 Diabetes Mellitus
T2DM
Type 2 diabetes mellitus