NCT05130047

Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Michael Camilleri, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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). Thirty patients will receive either aldafermin (NGM282) or placebo, not both. The study includes a 7 to 28-day long prescreen period and a 28-day long treatment period for a maximum study duration of 56 days. Bowel pattern will be assessed by patient-recorded daily bowel pattern diaries. Serum 7-alpha C4 (C4) and fibroblast growth factor 19 (FGF-19) and fecal bile acids will be measured at baseline and Day 14 and Day 28 of treatment. Safety will be assessed through regular monitoring of adverse events, clinical laboratory results, 12-lead ECGs, physical examinations, and vital signs.

Conditions

• Chronic Diarrhea
• Irritable Bowel Syndrome With Diarrhea
• Bile Acid Malabsorption
• Bile Acid Diarrhea
• Bile Acid Malabsorption Syndrome Type II
• Functional Diarrhea

Interventions

Type	Name	Description
DRUG	Aldafermin	1 mg solution
DRUG	Placebo	Aldafermin placebo solution

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2021-11-22
• Last updated: 2023-10-12
• Results posted: 2023-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study