Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04187339




Registration number
NCT04187339
Ethics application status
Date submitted
3/12/2019
Date registered
5/12/2019
Date last updated
21/07/2021

Titles & IDs
Public title
Study of NGM395 in Adult Participants
Scientific title
A Phase 1, Randomized, Placebo-controlled, Double-blind, Two-part Study to Evaluate the Safety and Tolerability of NGM395 in Adult Obese Patients (Part 1) and in Adult Patients With Nonalcoholic Fatty Liver Disease (NAFLD) (Part 2).
Secondary ID [1] 0 0
NGM395-OB-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
NAFLD 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NGM395
Treatment: Other - NGM395
Treatment: Other - NGM395
Treatment: Other - NGM395
Treatment: Other - NGM395
Treatment: Other - NGM395
Other interventions - Placebo

Experimental: NGM395 Dose 1 - NGM395 Subcutaneous Injection

Experimental: NGM395 Dose 2 - NGM395 Subcutaneous Injection

Experimental: NGM395 Dose 3 - NGM395 Subcutaneous Injection

Experimental: NGM395 Dose 4 - NGM395 Subcutaneous Injection

Experimental: NGM395 Dose 5 - NGM395 Subcutaneous Injection

Experimental: NGM395 Dose 6 - NGM395 Subcutaneous Injection

Placebo comparator: Placebo - Placebo


Treatment: Other: NGM395
NGM395 Dose 1

Treatment: Other: NGM395
NGM395 Dose 2

Treatment: Other: NGM395
NGM395 Dose 3

Treatment: Other: NGM395
NGM395 Dose 4

Treatment: Other: NGM395
NGM395 Dose 5

Treatment: Other: NGM395
NGM395 Dose 6

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
140 Days
Secondary outcome [1] 0 0
Serum Concentration of NGM395
Timepoint [1] 0 0
140 Days

Eligibility
Key inclusion criteria
Part 1:

1. Body mass index (BMI) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg.

Part 2:
2. Liver fat =8% as assessed by MRI-PDFF.
3. BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.
4. Waist circumference > 40 inches for males or > 35 inches for females.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1:

1. Diagnosed with type 2 diabetes (T2D) and/or the use of metformin, dipeptidyl peptidase-4 (DPP4) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, sulfonylurea agents, acarbose, or insulin for T2D within 3 months prior to Screening.
2. Subjects with T2D managed with diet alone with HbA1c level > 6.5% or fasting glucose = 126 mg/dL at Screening.
3. History of bariatric surgery.
4. Fasting triglycerides > 400 mg/dL at Screening.

Part 2:
5. Diagnosed with type 2 diabetes with a HbA1c >9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (SGLT2) inhibitors, acarbose, or insulin for T2D within 3 months prior to Screening.

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
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
13/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/04/2021
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
NGM Clinical Study Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NGM Biopharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study of NGM395 in adult participants.
Trial website
https://clinicaltrials.gov/study/NCT04187339
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/study/NCT04187339