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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