Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Functional Constipation

Treatments: Biological: NGM282; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02649062

15-0107

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 3 patient groups, including a placebo group

NGM282 Dose 1

Experimental group

Description:

NGM282

Treatment:

Biological: NGM282

NGM282 Dose 2

Experimental group

Description:

NGM282

Treatment:

Biological: NGM282

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo