CompletedPhase 1Results posted

A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD

Lead sponsor

Hanmi Pharmaceutical Company Limited

Asset

Efocipegtrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

Actual enrollment

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Eligibility highlights

•BMI ≥30•HbA1c ≤6.5%

Primary endpoints

•Treatment-emergent AEs (any)•Clinical Renal Function Lab Abnormalities•Systolic BP, change

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 IDNCT03744182

Org study IDHM-TRIA-102

Timeline

Milestones

Study start2018-11-01actual

Study first posted2018-11-16actual

Primary completion2020-03-18actual

Study completion2020-03-18actual

Last update posted2025-01-27actual

Results first posted2025-01-27actual

Assets

Investigational agents

Efocipegtrutide

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Body mass index ≥ 30 kg/m2

•Waist circumference ≤ 57 inches

•Fasting Plasma Glucose < 7 mmol/L (126 mg/dL)

•HbA1c < 6.5%

•Controlled Attenuation Parameter ≥ 300 dB/m by FibroScan

•Liver fat by MRI-PDFF ≥ 10%.

Exclusion criteria

•A history of or active chronic liver disease due to alcohol, auto-immune, HIV, HBV or active HCV-infection or NASH disease

•Any history of clinically significant chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease (MELD) ≥ 10

•Previous surgical treatment for obesity

•Uncontrolled hypertension

•Any weight control treatment

•History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis

•History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment

•History or current diagnosis of heart disease

•Presence of clinically significant ECG findings

•History of renal disease or abnormal kidney function tests

•History of alcohol or illicit drug abuse

•Daily heavy use of cigarettes or any tobacco product

Endpoints (5)

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

Weight & body composition

Renal / kidney

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Body Mass Index

Time frame:baseline and 12 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Mean · kg/m2	95% CI
0.01 mg/kg HM15211	35.46	-
0.02 mg/kg HM15211	32.91	-
0.04 mg/kg HM15211	37.86	-
0.06 mg/kg HM15211	40.13	-
0.08 mg/kg HM15211	35.74	-
Placebo	34.61	-

Renal / kidney

1 endpoint

Primary/protocol endpoint/low confidence

Incidence of Clinical Renal Function Lab Abnormalities

Time frame:baseline and 12 weeks

change from baseline, descriptive

Posted result

Group	Mean · mmol/L	95% CI
HM15211 0.01 mg/kg	-1.111	-
HM15211 0.02 mg/kg	-0.238	-
HM15211 0.04 mg/kg	0.036	-
HM15211 0.06 mg/kg	-0.754	-
HM15211 0.08 mg/kg	-0.893	-
Placebo	0.190	-

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

Vital Signs

Time frame:baseline and 12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Mean · mmHg	95% CI
HM15211 0.01 mg/kg	7.2	-
HM15211 0.02 mg/kg	7.1	-
HM15211 0.04 mg/kg	-0.7	-
HM15211 0.06 mg/kg	-3.3	-
HM15211 0.08 mg/kg	-4.5	-
Placebo	2.2	-

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants With Adverse Events

Time frame:12 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Participants	95% CI
HM15211 0.01 mg/kg	7	-
HM15211 0.02 mg/kg	9	-
HM15211 0.04 mg/kg	9	-
HM15211 0.06 mg/kg	8	-
HM15211 0.08 mg/kg	6	-
Placebo	8	-

Primary/protocol endpoint

12-lead ECG

Time frame:baseline and 12 weeks

change from baseline, descriptive

Posted result

Group	Mean · milliseconds	95% CI
HM15211 0.01 mg/kg	4.2	-
HM15211 0.02 mg/kg	1.3	-
HM15211 0.04 mg/kg	-1.3	-
HM15211 0.06 mg/kg	0	-
HM15211 0.08 mg/kg	-2.2	-
Placebo	2.5	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.