Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

NCT ID: NCT02649062

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NGM282 Dose 1

NGM282

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

NGM282 Dose 2

NGM282

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NGM Biopharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen J Rossi, PharmD

Role: STUDY_DIRECTOR

NGM Biopharmaceuticals, Inc

Locations

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NGM Clinical Study Site 1

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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15-0107

Identifier Type: -

Identifier Source: org_study_id

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