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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - NGM282
Other interventions - Placebo

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


Other interventions: NGM282


Other interventions: Placebo
Intervention code [1] 0 0
Other interventions
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
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in
patients with nonalcoholic steatohepatitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02443116
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02443116