CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Aldafermin +1 moredrug
Likely dose
Aldafermin 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05130047
NCT05130047Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo Controlled Trial of Aldafermin (NGM282) for Treatment of Chronic Diarrhea Due to Bile Acid Malabsorption (BAM)

Michael Camilleri, MD·interventional·Posted Nov 22, 2021·Updated Oct 12, 2023

In Brief

A Phase 2 clinical trial evaluating Aldafermin and Placebo for Chronic Diarrhea and 5 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This single-center, randomized, double-blind, placebo-controlled study is designed to compare effects of aldafermin, (NGM282), 1 mg, and placebo given daily by subcutaneous injection on bowel functions and hepatic synthesis and fecal excretion of bile acids in patients with diarrhea associated with bile acid malabsorption (BAM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Diarrhea, Irritable Bowel Syndrome With Diarrhea, Bile Acid Malabsorption, Bile Acid Diarrhea, Bile Acid Malabsorption Syndrome Type II, Functional Diarrhea
CountriesUnited States
CollaboratorsNGM Biopharmaceuticals, Inc

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedNov 22, 2021
Enrollment StartDec 1, 2021
Primary CompletionNov 8, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.6 years ago

Interventions

Aldafermindrug

1 mg solution

Placebodrug

Aldafermin placebo solution