GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 2

A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

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

Lead sponsor

Carmot Therapeutics, Inc.

Asset

CT-388

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

360

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7-10.5%

Primary endpoints

•Body weight, % change•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06628362

Org study IDCT-388-104

Secondary IDXC45544Roche Protocol Number

Timeline

Milestones

Study first posted2024-10-08actual

Study start2024-11-21actual

Last update posted2026-04-17actual

Primary completion2026-06-01estimated

Study completion2026-09-24estimated

Assets

Investigational agents

CT-388

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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, 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

Exclusion criteria

•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

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

12 endpoints

Primary/protocol endpoint

Percent Change in Body Weight from Baseline to Week 36

Time frame:Baseline to Week 36

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Body Weight from Baseline to Week 48

Time frame:Baseline to Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36

Time frame:Baseline and Week 36

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48

Time frame:Baseline and Week 48

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent Change in Body Weight from Baseline to Week 28

Time frame:Baseline and Week 28

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48

Time frame:Baseline to Weeks 36 and 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48

Time frame:Baseline, Weeks 36 and 48

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference from Baseline to Weeks 36 and 48

Time frame:Baseline, Weeks 36 and 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Hip Circumference from Baseline to Weeks 36 and 48

Time frame:Baseline, Weeks 36 and 48

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48

Time frame:Baseline, Weeks 36 and 48

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48

Time frame:Baseline, Weeks 36 and 48

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/protocol endpoint

Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36

Time frame:Baseline to Week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c from Baseline to Week 48

Time frame:Baseline to Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48

Time frame:Weeks 36 and 48

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c from Baseline to Weeks 16 and 28

Time frame:Baseline to Weeks 16 and 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48

Time frame:Weeks 16, 28, 36, and 48

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48

Time frame:Weeks 16, 28, 36, and 48

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, ≥10% weight-loss responders

LOINC 4548-4

Secondary/protocol endpoint

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

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders

Secondary/protocol endpoint

Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48

Time frame:Baseline to Weeks 16, 28, 36, and 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48

Time frame:Baseline to Weeks 16, 28, 36, and 48

change from baseline, improvement

Secondary/protocol endpoint

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 from baseline, improvement

Secondary/protocol endpoint

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

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.