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CompletedNCT02649062Updated Mar 30, 2018

Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

A Phase 1/2 interventional study of NGM282 and Placebo in Functional Constipation, sponsored by NGM Biopharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-30.

Sponsored by NGM Biopharmaceuticals, Inc · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Functional Constipation

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03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 31 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

NGM Biopharmaceuticals, Inc is the lead sponsor of 26 studies on the registry; 1 is open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Structural or metabolic diseases/conditions that affect the GI system
  • Diagnosis of dyspepsia, IBS, or significant gastrointestinal symptoms
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    NGM282 Dose 1

    NGM282

    Biological: NGM282

  • Experimental
    NGM282 Dose 2

    NGM282

    Biological: NGM282

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

Interventions

  • BiologicalNGM282
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Effect on Colon Transit, as measured by the movement of food through the colon

    Time frame: 9 days

Secondary outcomes

  1. Clinical Laboratory Assessments

    Time frame: 14 days

07

Study locations

1 site
  • NGM Clinical Study Site 1
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02649062
Lead sponsor
NGM Biopharmaceuticals, Inc
Responsible party
Sponsor
First posted
Jan 7, 2016
Start date
Dec 2015
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Mar 30, 2018

Study contacts

Stephen J Rossi, PharmD
study director · NGM Biopharmaceuticals, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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