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Growth Hormone Secretagogue Receptor Agonist

aldafermin for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by NGM Biopharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

Study Summary

This trial evaluates aldafermin, a potential treatment for cirrhosis, in a group of patients with the disease. The study is double-blind, meaning that neither the patients nor the researchers know who is receiving the active drug or the placebo.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in Enhanced Liver Fibrosis (ELF) score.
Safety assessed by reported and observed adverse events.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Daily 3 mg doseExperimental Treatment1 Intervention
Administered by subcutaneous injection
Group II: Daily 1 mg doseExperimental Treatment1 Intervention
Administered by subcutaneous injection
Group III: Daily 0.3 mg doseExperimental Treatment1 Intervention
Administered by subcutaneous injection
Group IV: PlaceboPlacebo Group1 Intervention
Administered by subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aldafermin
2020
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor
23 Previous Clinical Trials
2,061 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
463 Patients Enrolled for Non-alcoholic Fatty Liver Disease
NGM Study DirectorStudy DirectorNGM Biopharmaceuticals
9 Previous Clinical Trials
993 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
463 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

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

How many facilities are offering this clinical trial?

"At this time, the research team is recruiting from 36 sites across the country: Durham, Kansas City, Fresno and various other locations. To lessen travel requirements it's best to select a clinic near your residence if you decide to join in on the trial."

Answered by AI

Is this an unprecedented research endeavor?

"Presently, two trials involving aldafermin are taking place in 46 cities and 10 nations. This drug was initially evaluated in 2020 by NGM Biopharmaceuticals, Inc., with 160 participants completing their Phase 2 trial. Since then, 18329 subsequent experiments have been executed."

Answered by AI

Does the criteria for this trial encompass elderly individuals?

"Participants of this research must fall within the bracket of 18 to 75 years old. This trial has 98 studies for minors, and 583 for those who are more senior in age."

Answered by AI

Is this research endeavor actively searching for participants?

"Evidenced by the clinicaltrials.gov website, this trial has ended its recruitment period; having been first posted on March 23rd 2020 and last updated on March 4th 2022. However, 657 other medical trials are currently enrolling patients at present."

Answered by AI

How has aldafermin been evaluated for its safety in humans?

"Our team at Power evaluated aldafermin's safety on a scale of 1 to 3, and gave it an assessment of 2. This is because the drug has only been subject to Phase 2 trials, thus there are some metrics that suggest its safe but no data supporting efficacy."

Answered by AI

Could you provide details on past experiments conducted using aldafermin?

"In 2020, aldafermin was initially researched at the NGM Clinical Study Site with over 18 thousand trials concluding since then. Presently, there are 2 active studies in Durham, North carolina and various other locations across the globe."

Answered by AI

How many participants are engaged in this experiment?

"At present, this clinical trial is not recruiting new patients. The study was initially added to the database on March 23rd 2020; however, it hasn't been updated since March 4th 2022. If you're searching for alternative research opportunities, there are 655 experiments related to nonalcoholic steatohepatitis that need volunteers and two tests involving aldafermin admitting participants."

Answered by AI

Is it possible to become a participant in this medical experiment?

"This clinical trial seeks 160 qualified individuals aged 18-75 suffering from nonalcoholic steatohepatitis. The application necessitates that prospective participants have liver biopsies confirming NASH cirrhosis, compensated cirrhosis due to NASH, and other key criteria."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
2020. "Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04210245.
~32 spots leftby Apr 2025
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