DelfaGLP-1 Atlas

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CompletedPhase 2

A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

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

Asset

CT-388

Subcutaneous · GLP-1 / GIP dual

Listed sites

34

Recruiting sites

—

Enrollment

469

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-30

Primary endpoint

•Body weight, % 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 IDNCT06525935
Org study IDCT-388-103
Secondary IDXC45526Roche Protocol Number

Timeline

Milestones

Study first posted2024-07-29actual
Study start2024-08-16actual
Primary completion2025-12-08actual
Study completion2025-12-08actual
Last update posted2026-04-17actual

Assets

Investigational agents

CT-388

Study populations

Who this study enrolls

Obesity / overweight

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) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 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

Exclusion criteria

•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 plan 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

Endpoints (16)

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

Weight & body composition
9
Glycemic / diabetes
7

Weight & body composition

9 endpoints
Primary/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 48

Time frame:Baseline and Week 48

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute Change in Body Weight (kg) from Baseline to Week 48

Time frame:Baseline to Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Body Weight from Baseline to Week 48 by Obesity Class

Time frame:Baseline to Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI) from Baseline to Week 48

Time frame:Baseline to Week 48

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference from Baseline to Week 48

Time frame:Baseline to Week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Hip Circumference from Baseline to Week 48

Time frame:Baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-to-Hip Ratio from Baseline to Week 48

Time frame:Baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-to-Height Ratio from Baseline to Week 48

Time frame:Baseline to Week 48

change from baseline, improvement

Glycemic / diabetes

7 endpoints
Secondary/protocol endpoint

Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48

Time frame:Baseline to Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose from Baseline to Week 48

Time frame:Baseline to Week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Insulin from Baseline to Week 48

Time frame:Baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting C-peptide from Baseline to Week 48

Time frame:Baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48

Time frame:Baseline to Week 48

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48

Time frame:Baseline to Week 48

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c

Time frame:Baseline and Week 48

categorical status, 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.