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

NCT05130047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-12

Study results available
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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).

Conditions

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

Interventions

DRUG

Aldafermin

1 mg solution

DRUG

Placebo

Aldafermin placebo solution

Sponsors & Collaborators

  • NGM Biopharmaceuticals, Inc

    collaborator INDUSTRY

  • Michael Camilleri, MD

    lead OTHER

Principal Investigators

  • Michael Camilleri, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-11-08
Completion
2022-11-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130047 on ClinicalTrials.gov