NCT02649062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

January 4, 2016

Last Update Submit

March 28, 2018

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

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

    9 days

Secondary Outcomes (1)

  • Clinical Laboratory Assessments

    14 days

Study Arms (3)

NGM282 Dose 1

EXPERIMENTAL

NGM282

Biological: NGM282

NGM282 Dose 2

EXPERIMENTAL

NGM282

Biological: NGM282

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

NGM282BIOLOGICAL
NGM282 Dose 1NGM282 Dose 2
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NGM Clinical Study Site 1

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

aldafermin

Study Officials

  • Stephen J Rossi, PharmD

    NGM Biopharmaceuticals, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 7, 2016

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)