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Phase II: CT-388 in Obesity with Type 2 Diabetes Mellitus (CT-388-104)

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 Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese with Type 2 Diabetes Mellitus

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 who are overweight or obese with Type 2 diabetes mellitus (T2DM).

T2DM: Type 2 diabetes mellitus

Primary Endpoints

Percent Change in Body Weight from Baseline to Week 36 [Time Frame: Baseline to Week 36]
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36 [Time Frame: Baseline to Week 36]

Secondary Endpoints

Percent Change in Body Weight from Baseline to Week 48 [Time Frame: Baseline to Week 48]
Change in HbA1c from Baseline to Week 48 [Time Frame: Baseline to Week 48]
Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48 [Time Frame: Weeks 36 and 48]
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36 [Time Frame: Baseline and Week 36]
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48 [Time Frame: Baseline and Week 48]
Percent Change in Body Weight from Baseline to Week 28 [Time Frame: Baseline and Week 28]
Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48 [Time Frame: Baseline to Weeks 36 and 48]
Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class [Time Frame: Baseline to Weeks 16, 28, 36, and 48]
Change in HbA1c from Baseline to Weeks 16 and 28 [Time Frame: Baseline to Weeks 16 and 28]
Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class [Time Frame: Baseline to Weeks 16, 28, 36, and 48]
Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48 [Time Frame: Weeks 16, 28, 36, and 48]
Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48 [Time Frame: Weeks 16, 28, 36, and 48]
Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48 [Time Frame: Weeks 16, 28, 36, and 48]
Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48 [Time Frame: Baseline, Weeks 16, 28, 36, and 48]
Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48 [Time Frame: Baseline, Weeks 16, 28, 36, and 48]
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48 [Time Frame: Baseline, Weeks 36 and 48]
Change in Waist Circumference from Baseline to Weeks 36 and 48 [Time Frame: Baseline, Weeks 36 and 48]
Change in Hip Circumference from Baseline to Weeks 36 and 48 [Time Frame: Baseline, Weeks 36 and 48]
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48 [Time Frame: Baseline, Weeks 36 and 48]
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48 [Time Frame: Baseline, Weeks 36 and 48]
Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48 [Time Frame: Baseline to Weeks 16, 28, 36, and 48]
Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48 [Time Frame: Baseline to Weeks 16, 28, 36, and 48]
Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48 [Time Frame: Baseline to Weeks 16, 28, 36, and 48]
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48 [Time Frame: Baseline to Weeks 16, 28, 36, and 48]

HbA1c: Glycated Hemoglobin
SMBG: Self-Monitored Blood Glucose
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) ≥25.0 kg/m^2
Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World Health Organization classification or other locally applicable standards
Have an HbA1c ≥7% and ≤10.5%
Management of T2DM with diet and exercise alone or diet and exercise and treatment with metformin or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor as monotherapy or in combination, per approved local label
At least one self-reported unsuccessful diet/exercise effort to lose body weight

Have Type 1 Diabetes Mellitus (T1DM), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
Have had 1 or more episodes of Level 3 hypoglycemia or have had hypoglycemia unawareness within 3 months prior to screening
Have history or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
Have evidence of clinically significant autonomic neuropathy (symptoms may include resting tachycardia, orthostatic hypotension, or diabetic diarrhea)
Had treatment with any oral antihyperglycemic medications, with the exception of metformin or SGLT-2 inhibitors, within 3 months prior to screening or planned concurrent treatment with these medications during the study
Had treatment with injectable antihyperglycemic medication, with the exception of short-term insulin, within 6 months prior to screening or planned concurrent treatment with these medications during the study
Self-reported body weight change of >5 kg within 3 months before screening
Any unbalanced/extreme diets, such as very low calorie, low carbohydrate, very high protein, ketogenic, or intermittent diets, within 3 months of the screening visit, or plan to be on such diets during the study
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 or procedure for obesity, except for liposuction or abdominoplasty if performed >1 year prior to screening. Participants with a history of devices, such as LAP-BAND^® or intragastric balloon, are permitted, if devices were removed >1 year prior to screening.
History of clinically significant or active gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction, intestinal obstruction), or chronic use of medications that directly affect GI motility
History of chronic pancreatitis or acute pancreatitis or have signs and symptoms of acute pancreatitis at screening
Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
History or diagnosis of significant active or unstable major depressive disorder or any history/diagnosis of other severe psychiatric conditions (e.g., schizophrenia; bipolar disorder; other serious mood disorder or anxiety disorder, or hyperactivity disorder) within the last year before screening
History of any hematologic conditions that may interfere with HbA1c measurement (e.g., hemolytic anemias, sickle cell disease, other hemoglobinopathies)
Family or personal history of medullary thyroid carcinoma
Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method as required per protocol

BMI: Body mass index
SGLT-2: sodium-glucose cotransporter-2
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: NCT06628362

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.

Looking for more information?

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