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Peptide Hormone

Aldafermin for Irritable Bowel Syndrome

Phase 2
Waitlist Available
Led By Michael Camilleri, M.D.
Research Sponsored by Michael Camilleri, MD
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 14 days, 28 days

Summary

This trial tests a new treatment for patients with diarrhea caused by poor bile acid regulation. The treatment aims to improve bowel function and reduce diarrhea.

Eligible Conditions
  • Functional Diarrhea
  • Bile Acid Malabsorption Syndrome
  • Irritable Bowel Syndrome
  • Bile Acid Malabsorption
  • Bile Acid Diarrhea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days, 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days, 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Stool Consistency From Baseline to Day 28
Fasting Serum C4 Levels
Secondary study objectives
Abdominal Pain Score
Bowel Movements
Proportion of Fecal Primary (CDCA + CA) Bile Acid as Measured in a Random Stool Sample by a Validated Laboratory Assay.
+4 more

Side effects data

From 2022 Phase 2 trial • 30 Patients • NCT05130047
33%
Infections
27%
Increased LDL Cholesterol
20%
Irritation at injection site
20%
Other gastrointestinal symptoms
20%
Musculoskeletal
13%
Metabolism and Nutrition
13%
Increased diarrhea
13%
Reanl and urinary
13%
Headache
7%
Myocardial infarction
7%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aldafermin (NGM282)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Aldafermin (NGM282)Experimental Treatment1 Intervention
Aldafermin (NGM282) is an investigational medication. It is an engineered analog of FGF-19 which reduces synthesis of bile acids and diarrhea caused by elevated bile acids. Participants receive aldafermin (NGM282) 1 mg given by subcutaneous injection once daily for 28 days.
Group II: PlaceboPlacebo Group1 Intervention
A placebo looks exactly like the study drug but contains no active ingredients. It is used to learn if the effects seen are truly from the study drug. Participants receive placebo solution matching aldafermin (NGM282) given by subcutaneous injection once daily for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldafermin
2021
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Michael Camilleri, MDLead Sponsor
2 Previous Clinical Trials
172 Total Patients Enrolled
NGM Biopharmaceuticals, IncIndustry Sponsor
23 Previous Clinical Trials
2,206 Total Patients Enrolled
Michael Camilleri, M.D.Principal InvestigatorMayo Clinic
2 Previous Clinical Trials
692 Total Patients Enrolled
~8 spots leftby Oct 2025
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