Current partner codePEPTIDESDE
NCT03744182·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

66

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

HM15211

A sterile solution of HM15211 contained in pre-filled syringes

DRUG

Placebo of HM15211

A sterile, matching solution in pre-filled syringes

Timeline

From registration to results.

  1. First posted

    Nov 16, 2018

  2. Study start

    Nov 1, 2018

  3. Primary completion

    Mar 18, 2020

  4. Study completion

    Mar 18, 2020

  5. Results posted

    Jan 27, 2025

  6. Registry updated

    Jan 27, 2025

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Body Mass Index

Time frame · baseline and 12 weeks

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
Yes

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

ProSciento Inc.

Chula Vista, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Efocipegtrutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.