DRUG
HM15211
A sterile solution of HM15211 contained in pre-filled syringes
Status
Completed
Phase
Phase 1
Enrollment
66
Locations
1
Results
Posted
Publications
0
Study 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
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
DRUG
A sterile solution of HM15211 contained in pre-filled syringes
DRUG
A sterile, matching solution in pre-filled syringes
Timeline
First posted
Nov 16, 2018
Study start
Nov 1, 2018
Primary completion
Mar 18, 2020
Study completion
Mar 18, 2020
Results posted
Jan 27, 2025
Registry updated
Jan 27, 2025
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
Body Mass Index
Time frame · baseline and 12 weeks
Change of Body Mass Index from baseline to 12 weeks after IP injection
Eligibility
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
United States. Showing up to 24 locations stored in the fast local snapshot.
ProSciento Inc.
Chula Vista, California, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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