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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02443116




Registration number
NCT02443116
Ethics application status
Date submitted
11/05/2015
Date registered
13/05/2015
Date last updated
11/09/2020

Titles & IDs
Public title
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
Scientific 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 Administered for Up to 24 Weeks in Patients With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Secondary ID [1] 0 0
15-0105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis (NASH) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placebo comparator: Cohort 1 - Placebo - Cohort 1 - Placebo

Experimental: Cohort 1 - NGM282 3mg - Cohort 1 - NGM282 3mg

Experimental: Cohort 1 - NGM282 6mg - Cohort 1 - NGM282 6mg

Experimental: Cohort 2 - NGM282 0.3mg - Cohort 2 - NGM282 0.3mg

Placebo comparator: Cohort 2 - NGM282 1mg - Cohort 2 - NGM282 1mg

Experimental: Cohort 2 - NGM282 3mg - Cohort 2 - NGM282 3mg

Experimental: Cohort 3 - NGM282 1mg - Cohort 3 - NGM282 1mg

Placebo comparator: Cohort 4 - Placebo - Cohort 4 - Placebo

Experimental: Cohort 4 - NGM282 1mg - Cohort 4 - NGM282 1mg
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in absolute liver fat content as measured by MRI from Baseline to Week 24
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Change in percentage liver fat content as measure by MRI from Baseline to Week 24
Timepoint [1] 0 0
24 weeks

Eligibility
Key inclusion criteria
* Males or females, between 18 and 75 years of age, inclusive
* Histologically confirmed NASH diagnosis
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinically significant acute or chronic liver disease
* Prior liver transplantation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/01/2020
Sample size
Target
Accrual to date
Final
254
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
NGM Clinical Study Site 703 - Sydney
Recruitment hospital [2] 0 0
NGM Clinical Study Site 704 - Adelaide
Recruitment hospital [3] 0 0
NGM Clinical Study Site 701 - Melbourne
Recruitment hospital [4] 0 0
NGM Clinical Study Site 705 - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Puerto Rico
State/province [12] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NGM Biopharmaceuticals, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
NGM Biopharmaceuticals Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
NGM Study Director
Address 0 0
NGM Biopharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02443116