Not yet recruitingPhase 1

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Enicepatide in Generally Healthy Adult Chinese Participants

A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Enicepatide in Adult Chinese Participants With Body Mass Index ≥23.0 kg/m2

Lead sponsor

Hoffmann-La Roche

Asset

CT-388

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI ≥23

Primary endpoints

•Incidence and Severity of Adverse Events•Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum•Pulse Rate

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07626515

Org study IDYP46402

Timeline

Milestones

Study first posted2026-06-04actual

Last update posted2026-06-04actual

Study start2026-06-26estimated

Primary completion2027-04-30estimated

Study completion2027-05-30estimated

Assets

Investigational agents

CT-388

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•No evidence of active or chronic disease as determined by detailed medical and surgical history and the results of a physical examination, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests

•BMI ≥23 kg/m^2 at screening

•Agreement to adhere to the contraception requirements

Exclusion criteria

•History of acute or chronic pancreatitis

•History of clinically significant gallbladder disease in the opinion of the investigator

•History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder

•History or presence of an abnormal ECG that is deemed clinically significant in the opinion of the investigator

•Clinically significant abnormalities (as judged by the investigator) in laboratory test results

•History or presence of clinically significant cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, pulmonary disease, or history of any of these diseases with renal, hepatic, or cardiopulmonary dysfunction

Endpoints (14)

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

Cardiometabolic biomarkers

Weight & body composition

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Absolute Change From Baseline in Body Weight

Time frame:Baseline through Week 24

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline through Week 24

percent change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint

Change from Baseline in Pulse Rate

Time frame:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

change from baseline, improvement

Primary/protocol endpoint

Change from Baseline in Systolic Blood Pressure

Time frame:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

change from baseline, improvement

Primary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure

Time frame:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

change from baseline, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Incidence and Severity of Adverse Events

Time frame:Baseline to Safety Follow-Up (27 weeks)

descriptive

Primary/protocol endpoint

Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade

Time frame:Baseline to Safety Follow-Up (27 weeks)

event count, event

Secondary/protocol endpoint

Plasma Concentration of Enicepatide

Time frame:At prespecified time points from Day 1 to Day 190

concentration, descriptive

Secondary/protocol endpoint

Maximum Plasma Concentration Observed (Cmax) of Enicepatide

Time frame:At prespecified time points from Day 1 to Day 190

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax (Tmax) of Enicepatide

Time frame:At prespecified time points from Day 1 to Day 190

time to event, event

Secondary/protocol endpoint

Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide

Time frame:At prespecified time points from Day 1 to Day 190

concentration, descriptive

Secondary/protocol endpoint

Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide

Time frame:At prespecified time points from Day 1 to Day 190

threshold achievement, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Change from Baseline in Respiratory Rate

Time frame:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change from Baseline in Body Temperature

Time frame:At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.