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CompletedPhase 1

A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus

A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus

Asset

CT-388

Subcutaneous · GLP-1 / GIP dual

Listed sites

2

Recruiting sites

Enrollment

129

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

BMI 27-40

Primary endpoint

Treatment-emergent AEs (any)

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 IDNCT04838405
Org study IDCT-388-101

Timeline

Milestones

Study first posted2021-04-09actual
Study start2021-04-29actual
Primary completion2024-06-18actual
Study completion2024-08-02actual
Last update posted2025-10-20actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Males or females
18-65 years old, inclusive
BMI 27.0-40.0, inclusive
Stable body weight for 2 months

Exclusion criteria

Significant medical history
Uncontrolled hypertension
History of malignancy

Endpoints (7)

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

Safety / tolerability / PK
4
Glycemic / diabetes
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in mean body weight

Time frame:Baseline up to 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in mean glucose levels

Time frame:Baseline up to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in mean insulin levels

Time frame:Baseline up to 24 weeks

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events as assessed by self-report

Time frame:Baseline up to 24 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the concentration versus time curve (AUC)

Time frame:Baseline up to 24 weeks

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed drug concentration (Cmax)

Time frame:Baseline up to 24 weeks

Cmax

concentration, descriptive

Secondary/protocol endpoint

Elimination half-life

Time frame:Baseline up to 24 weeks

Half-life

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.