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HM15211 for Non-alcoholic Steatohepatitis (NASH)

Phase 2
Recruiting
Research Sponsored by Hanmi Pharmaceutical Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ≥ 18 to ≤ 70 years.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new drug to treat NASH, a liver condition, to see if it is effective and safe.

Who is the study for?
Adults aged 18-70 with non-cirrhotic NASH and liver fibrosis stages F1-F3, confirmed by a biopsy within the last 6 months. Participants must have at least 8% liver fat on MRI-PDFF and a stable body weight for the past three months. Excluded are those with significant chronic liver diseases, recent use of certain NAFLD-related therapies, Type 1 diabetes or specific Type 2 diabetes treatments.Check my eligibility
What is being tested?
The trial is testing HM15211's effectiveness over a year in treating NASH compared to a placebo. It's designed to see if this treatment can improve fatty liver disease without causing harm or discomfort to patients.See study design
What are the potential side effects?
While not specified here, common side effects for similar treatments may include gastrointestinal issues like nausea or diarrhea, potential allergic reactions, fatigue, headaches and possibly an impact on blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
pharmacodynamic (PD) effect of HM15211

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HM15211Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HM15211
2018
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Hanmi Pharmaceutical Company LimitedLead Sponsor
190 Previous Clinical Trials
60,865 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
66 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

HM15211 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04505436 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: HM15211, Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: HM15211 Highlights & Side Effects. Trial Name: NCT04505436 — Phase 2
HM15211 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04505436 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different locations can patients enroll in this trial?

"Presently, this research is being conducted in 44 different locations, including but not limited to Dallas, Arlington and Miami Lakes. If you are interested in enrolling, it would be beneficial to pick a centre near your residence to reduce travel time commitments."

Answered by AI

Are there any current openings in this trial for willing participants?

"Yes, the trial is recruiting patients right now. The original posting was on July 31st, 2020 and the most recent update was on August 22nd of this year."

Answered by AI

Who meets the requirements to enroll in this clinical trial?

"The ideal candidate for this clinical trial concerning nonalcoholic steatohepatitis must be between 18 and 70 years old. Presently, the research team is looking to enroll around 217 individuals."

Answered by AI

Does this research involve elderly individuals?

"Patients between 18-70 years old can enroll in this trial, though there are 24 other trials more specific to those under 18 and 203 for patients over 65."

Answered by AI

Has the FDA given HM15211 the green light?

"The safety of HM15211 was given a score of 2. This is due to the lack of efficacy data, as this is only a Phase 2 trial."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Other
North Carolina
Tennessee
How old are they?
65+
18 - 65
What site did they apply to?
Tandem Clinical Research, LLC
Wake Research Associates, LLC (WRA)
University of Maryland Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I was on a liver Nash study in New Orleans in 2020 and had to quit when I moved here to Virginia. Is it was with Tandem Clinical Research. Dr. Schiffman did a liver biopsy on me in July 2022 which showed stage two liver fibrosis. I’ve been seeking a clinical trial to help preventing the fibrosis from progressing.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do screening visits take? What are the most common side effects of this drug? How long is the study and am I compensated for time and travel, etc.?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects
2020. "Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505436.
All > Fatty Liver Disease
~51 spots leftby May 2025
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