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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

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

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

Myocardial infarction

Abdominal pain

100%

80%

60%

40%

20%

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

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