Phase 2 Study of NGM282 in Patients With Type 2 Diabetes
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Activity of NGM282 Administered for 28 Days to Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
81
2 countries
9
Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus
Started Sep 2013
Shorter than P25 for phase_2 diabetes-mellitus
9 active sites
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
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 11, 2013
CompletedFirst Posted
Study publicly available on registry
September 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedNovember 17, 2015
November 1, 2015
1 year
September 11, 2013
November 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Fasting Plasma Glucose
28 days
Secondary Outcomes (2)
HbA1c
28 days
Lipids
28 days
Study Arms (4)
NGM282 Dose 1
EXPERIMENTALNGM Dose 1
NGM282 Dose 2
EXPERIMENTALNGM Dose 2
NGM282 Dose 3
EXPERIMENTALNGM Dose 3
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Males or females, between 18 and 70 years of age, inclusive
- BMI range of 24-40 kg/m2, inclusive
- No active coronary artery disease
- Resting heart rate in the range of 40-100 bpm
You may not qualify if:
- Diagnosis of Type 1 diabetes
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
NGM Clinical Study Site 6103
Melbourne, Victoria, Australia
NGM Clinical Study Site 6104
Melbourne, Victoria, Australia
NGM Clinical Study Site 6101
Perth, Western Australia, Australia
NGM Clinical Study Site 6403
Auckland, New Zealand
NGM Clinical Study Site 6405
Auckland, New Zealand
NGM Clinical Study Site 6401
Christchurch, New Zealand
NGM Clinical Study Site 6406
Dunedin, New Zealand
NGM Clinical Study Site 6404
Tauranga, New Zealand
NGM Clinical Study Site 6402
Wellington, New Zealand
Related Publications (1)
DePaoli AM, Zhou M, Kaplan DD, Hunt SC, Adams TD, Learned RM, Tian H, Ling L. FGF19 Analog as a Surgical Factor Mimetic That Contributes to Metabolic Effects Beyond Glucose Homeostasis. Diabetes. 2019 Jun;68(6):1315-1328. doi: 10.2337/db18-1305. Epub 2019 Mar 12.
PMID: 30862680DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alex M DePaoli, MD
NGM Biopharmaceuticals, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2013
First Posted
September 16, 2013
Study Start
September 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
November 17, 2015
Record last verified: 2015-11