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

NCT03744182 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HM-TRIA-102
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

NAFLD

Outcome Measures

Primary Outcomes (4)

• 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

  12 weeks

• Incidence of Clinical Renal Function Lab Abnormalities

  Observed Values and Change from Baseline in Renal Function of Urea Nitrogen

  baseline and 12 weeks

• Vital Signs

  Change from baseline in vital signs (Systolic Blood)

  baseline and 12 weeks

• 12-lead ECG

  Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF

  baseline and 12 weeks

Secondary Outcomes (1)

• Body Mass Index

  baseline and 12 weeks

Study Arms (2)

HM15211

EXPERIMENTAL

Drug: HM15211

Placebo

PLACEBO COMPARATOR

Drug: Placebo of HM15211

Interventions

HM15211 DRUG

A sterile solution of HM15211 contained in pre-filled syringes

HM15211

Placebo of HM15211 DRUG

A sterile, matching solution in pre-filled syringes

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

ProSciento Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: GAEUN PARK
• Organization: Hanmi Pharmaceutical Co., Ltd.

gaeun.park@hanmi.co.kr

+824108746

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 16, 2018
• Study Start: November 1, 2018
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2025-01

Locations

US (1)