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Lakewood Ranch, Florida

  • Nonalcoholic Steatohepatitis (NASH)

Purpose:

The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.


Criteria:

Inclusion Criteria: - Males or females, between 18 and 75 years of age, inclusive - Histologically confirmed NASH diagnosis Exclusion Criteria: - Clinically significant acute or chronic liver disease - Prior liver transplantation


Study is Available At:


Original ID:

15-0105


NCT ID:

NCT02443116


Secondary ID:


Study Acronym:


Brief Title:

Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)


Official Title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Multiple-center Study With Additional Open-label Single-blind and Placebo-controlled 24-Week Histology Cohorts to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administere


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NGM Biopharmaceuticals, Inc


Oversight Authority:

  • Australia: Department of Health and Ageing Therapeutic Goods Administration
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

6


Number of Groups:

0


Total Enrollment:

250


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:NGM Study Director
Study Director
NGM Biopharmaceuticals, Inc

Study Dates

Start Date:May 2015
Completion Date:September 2019
Completion Type:Anticipated
Primary Completion Date:September 2019
Primary Completion Type:Anticipated
Verification Date:August 2019
Last Changed Date:August 13, 2019
First Received Date:May 11, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in absolute liver fat content as measured by MRI from Baseline to Week 24
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in percentage liver fat content as measure by MRI from Baseline to Week 24
Time Frame:24 weeks
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:NGM282
Arm Name:NGM282 Dose 1
Intervention Type:Other
Name:Placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:NGM282 Dose 1
Description:NGM282
Study Arm Type:Experimental
Arm Name:NGM282 Dose 2
Description:NGM282
Study Arm Type:Experimental
Arm Name:NGM282 Dose 3
Description:NGM282
Study Arm Type:Experimental
Arm Name:NGM282 Dose 4
Description:NGM282
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo
Study Arm Type:Experimental
Arm Name:NGM282 Dose 5
Description:NGM282

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:NGM Biopharmaceuticals, Inc
Agency Class:Industry
Agency Type:Collaborator
Agency Name:NGM Biopharmaceuticals Australia Pty Ltd

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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