Clinical trial NCT03744182: A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NAFLD
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 12 weeks
measure: Incidence of Clinical Renal Function Lab Abnormalities
timeFrame: baseline and 12 weeks
measure: Vital Signs
timeFrame: baseline and 12 weeks
measure: 12-lead ECG
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Body Mass Index
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento Inc.
state: California
Study officials:
References: