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Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

Study of the Pharmacodynamics of NGM282 on Colonic Transit, Bile Acid Homeostasis, and Fecal Fat in Subjects With Functional Constipation and Healthy Individuals

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02649062
Enrollment
31
Registered
2016-01-07
Start date
2015-12-31
Completion date
2017-01-31
Last updated
2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Constipation

Brief summary

The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.

Interventions

BIOLOGICALNGM282
OTHERPlacebo

Sponsors

NGM Biopharmaceuticals, Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Functional constipation confirmed by modified Rome III criteria or Healthy Volunteer

Exclusion criteria

* Structural or metabolic diseases/conditions that affect the GI system * Diagnosis of dyspepsia, IBS, or significant gastrointestinal symptoms

Design outcomes

Primary

MeasureTime frame
Effect on Colon Transit, as measured by the movement of food through the colon9 days

Secondary

MeasureTime frame
Clinical Laboratory Assessments14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026