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Peptide Hormone
Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM)
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
- Bile acid malabsorption
- Functional Diarrhea
- Bile Acid Malabsorption Syndrome
- Irritable Bowel Syndrome
- Bile Acid Malabsorption
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days, 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days, 28 days
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 moreSide effects data
From 2022 Phase 2 trial • 30 Patients • NCT0513004733%
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
24 Previous Clinical Trials
2,506 Total Patients Enrolled
Michael Camilleri, M.D.Principal InvestigatorMayo Clinic
2 Previous Clinical Trials
692 Total Patients Enrolled