Study of NGM395 in Adult Participants
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).
1 other identifier
interventional
38
1 country
1
Brief Summary
Study of NGM395 in adult participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 obesity
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedStudy Start
First participant enrolled
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2021
CompletedJuly 21, 2021
July 1, 2021
8 months
December 3, 2019
July 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
140 Days
Secondary Outcomes (1)
Serum Concentration of NGM395
140 Days
Study Arms (7)
NGM395 Dose 1
EXPERIMENTALNGM395 Subcutaneous Injection
NGM395 Dose 2
EXPERIMENTALNGM395 Subcutaneous Injection
NGM395 Dose 3
EXPERIMENTALNGM395 Subcutaneous Injection
NGM395 Dose 4
EXPERIMENTALNGM395 Subcutaneous Injection
NGM395 Dose 5
EXPERIMENTALNGM395 Subcutaneous Injection
NGM395 Dose 6
EXPERIMENTALNGM395 Subcutaneous Injection
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Part 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:
- Liver fat ≥8% as assessed by MRI-PDFF.
- BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.
- Waist circumference \> 40 inches for males or \> 35 inches for females.
You may not qualify if:
- Part 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.
- Subjects with T2D managed with diet alone with HbA1c level \> 6.5% or fasting glucose ≥ 126 mg/dL at Screening.
- History of bariatric surgery.
- Fasting triglycerides \> 400 mg/dL at Screening.
- Part 2:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NGM Clinical Study Site
Brisbane, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
NGM Study Director
NGM Biopharmaceuticals, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 5, 2019
Study Start
February 13, 2020
Primary Completion
October 20, 2020
Study Completion
April 22, 2021
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share