NAFLDPhase 1NCT03744182

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

A Phase 1 study testing HM15211 in people with NAFLD, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: NAFLD
What is being tested?: HM15211
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2018to 18 Mar 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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%.

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

ProSciento Inc.
Chula Vista, California, 91911

Other trials in United States

About this study

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

This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD

Read the detailed description

This study will be single-blind and conducted in up to 6 cohorts comprising a total of up to 72 obese subjects with NAFLD. Each cohort will enroll subjects to ensure that at least 12 subjects per cohort will complete the study. Subjects will be randomized to investigational product (IP) or placebo in a 3:1 ratio via an Interactive Web Response System (IWRS). Per cohort (n=12 subjects), 9 subjects will be randomized to IP and 3 subjects to placebo. Cohorts may partially overlap after at least 9 subjects have completed 2-4 weeks of treatment (2 weeks of treatment is reached at Visit week 3) and a dose escalation decision has been made. Study drug will be administered weekly over a period of 12 weeks.

Conditions: NAFLD
Being tested: HM15211, Placebo of HM15211
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HM15211Drug
A sterile solution of HM15211 contained in pre-filled syringes
Placebo of HM15211Drug
A sterile, matching solution in pre-filled syringes

Study groups in NCT03744182
Study group	Role	What they receive
HM15211	Experimental	Not described Receives: Drug: HM15211
Placebo	Placebo comparator	Not described Receives: Drug: Placebo of HM15211

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Cardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation [cholelithiasis] were managed following a separate AE guidance document
Measured: 12 weeks
Incidence of Clinical Renal Function Lab Abnormalities
Observed Values and Change from Baseline in Renal Function of Urea Nitrogen
Measured: baseline and 12 weeks
Vital Signs
Change from baseline in vital signs (Systolic Blood)
Measured: baseline and 12 weeks
12-lead ECG
Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF
Measured: baseline and 12 weeks

Secondary outcomes (1)

Body Mass Index
Change of Body Mass Index from baseline to 12 weeks after IP injection
Measured: baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201818 Mar 2020

First posted16 Nov 2018
Study start1 Nov 2018
Primary completion18 Mar 2020
Study completion18 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NAFLDStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03744182
Sponsor's protocol ID: HM-TRIA-102
Status last verified: Jan 2025
First submitted: 12 Nov 2018
Last updated: 27 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All NAFLD trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
ClinicalTrials.gov ID: NCT03744182
Acronym / sponsor ID: HM-TRIA-102
Conditions: NAFLD
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 1 Nov 2018 (actual)
Primary completion: 18 Mar 2020 (actual)
Study completion: 18 Mar 2020 (actual)
First posted: 16 Nov 2018 (actual)
Results: Posted 27 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
HM15211	Experimental	Drug: HM15211
Placebo	Placebo comparator	Drug: Placebo of HM15211

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HM15211A sterile solution of HM15211 contained in pre-filled syringes	Drug	HM15211
Placebo of HM15211A sterile, matching solution in pre-filled syringes	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: 12 weeks
Cardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation [cholelithiasis] were managed following a separate AE guidance document
Incidence of Clinical Renal Function Lab Abnormalities
Time frame: baseline and 12 weeks
Observed Values and Change from Baseline in Renal Function of Urea Nitrogen
Vital Signs
Time frame: baseline and 12 weeks
Change from baseline in vital signs (Systolic Blood)
12-lead ECG
Time frame: baseline and 12 weeks
Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF

1 secondary outcome

Body Mass Index
Time frame: baseline and 12 weeks

Results and safety

Results posted to the registry on 27 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.01 mg/kg HM15211	9	9
0.02 mg/kg HM15211	10	10
0.04 mg/kg HM15211	12	10
0.06 mg/kg HM15211	9	9
0.08 mg/kg HM15211	9	8
Placebo	17	15

Primary outcome: Number of Participants With Adverse Events

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	HM15211 0.01 mg/kg n = 9	HM15211 0.02 mg/kg n = 10	HM15211 0.04 mg/kg n = 12	HM15211 0.06 mg/kg n = 9	HM15211 0.08 mg/kg n = 9	Placebo n = 17
Value	7	9	9	8	6	8

Primary outcome: Incidence of Clinical Renal Function Lab Abnormalities

Time frame: baseline and 12 weeks. Mean (Standard Deviation). Unit: mmol/L

Measure	HM15211 0.01 mg/kg n = 9	HM15211 0.02 mg/kg n = 10	HM15211 0.04 mg/kg n = 12	HM15211 0.06 mg/kg n = 9	HM15211 0.08 mg/kg n = 9	Placebo n = 17
Value	-1.111 (0.7240)	-0.238 (0.7142)	0.036 (1.1350)	-0.754 (0.7242)	-0.893 (0.5414)	0.190 (1.4962)

Primary outcome: Vital Signs

Time frame: baseline and 12 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	HM15211 0.01 mg/kg n = 9	HM15211 0.02 mg/kg n = 10	HM15211 0.04 mg/kg n = 12	HM15211 0.06 mg/kg n = 9	HM15211 0.08 mg/kg n = 9	Placebo n = 17
Value	7.2 (14.96)	7.1 (12.64)	-0.7 (13.33)	-3.3 (8.67)	-4.5 (18.80)	2.2 (12.27)

Primary outcome: 12-lead ECG

Time frame: baseline and 12 weeks. Mean (Standard Deviation). Unit: milliseconds

Measure	HM15211 0.01 mg/kg n = 9	HM15211 0.02 mg/kg n = 10	HM15211 0.04 mg/kg n = 12	HM15211 0.06 mg/kg n = 9	HM15211 0.08 mg/kg n = 9	Placebo n = 17
Value	4.2 (7.79)	1.3 (9.51)	-1.3 (7.14)	0 (3.59)	-2.2 (9.02)	2.5 (4.83)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 23 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.01 mg/kg HM15211	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
0.02 mg/kg HM15211	0 of 10 (0%)	9 of 10 (90%)	0 of 10
0.04 mg/kg HM15211	0 of 12 (0%)	9 of 12 (75%)	0 of 12
0.06 mg/kg HM15211	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
0.08 mg/kg HM15211	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Placebo	0 of 17 (0%)	8 of 17 (47.1%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HM15211 in people with NAFLD, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03744182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.