A Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD

• ClinicalTrials.gov Identifier: NCT03744182
• Recruitment Status: Completed
• First Posted: November 16, 2018
• Last Update Posted: September 29, 2021
• Sponsor: Hanmi Pharmaceutical Company Limited
• Information provided by (Responsible Party): Hanmi Pharmaceutical Company Limited

Study Description

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

Condition or disease	Intervention/treatment	Phase
NAFLD	Drug: HM15211; Drug: Placebo of HM15211	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211 in Obese Subjects With NAFLD
• Actual Study Start Date: November 1, 2018
• Actual Primary Completion Date: March 18, 2020
• Actual Study Completion Date: March 18, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: HM15211	Drug: HM15211; A sterile solution of HM15211 contained in pre-filled syringes
Placebo Comparator: Placebo	Drug: Placebo of HM15211; A sterile, matching solution in pre-filled syringes

Outcome Measures

Primary Outcome Measures :

1. Adverse Events [ Time Frame: 12 weeks ]
   Incidence of adverse events
2. Clinical lab abnormalities [ Time Frame: 12 weeks ]
   Incidence of clinical lab abnormalities
3. Physical examination [ Time Frame: 12 weeks ]
   Incidence and severity of clinical findings on physical examination
4. Vital signs [ Time Frame: 12 weeks ]
   Change from baseline in vital signs
5. 12-lead ECG [ Time Frame: 12 weeks ]
   Change from baseline in 12-lead ECG

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

ProSciento Inc.

Chula Vista, California, United States, 91911

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

More Information

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT03744182
• Other Study ID Numbers: HM-TRIA-102
• First Posted: November 16, 2018
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Diseases; Digestive System Diseases