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Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NGM282
Placebo
Sponsored by
NGM Biopharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diagnosis of Type 1 diabetes
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance

Sites / Locations

  • NGM Clinical Study Site 6103
  • NGM Clinical Study Site 6104
  • NGM Clinical Study Site 6101
  • NGM Clinical Study Site 6403
  • NGM Clinical Study Site 6405
  • NGM Clinical Study Site 6401
  • NGM Clinical Study Site 6406
  • NGM Clinical Study Site 6404
  • NGM Clinical Study Site 6402

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

NGM282 Dose 1

NGM282 Dose 2

NGM282 Dose 3

Placebo

Arm Description

NGM Dose 1

NGM Dose 2

NGM Dose 3

Placebo

Outcomes

Primary Outcome Measures

Fasting Plasma Glucose

Secondary Outcome Measures

HbA1c
Lipids

Full Information

First Posted
September 11, 2013
Last Updated
November 14, 2015
Sponsor
NGM Biopharmaceuticals, Inc
Collaborators
NGM Biopharmaceuticals Australia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01943045
Brief Title
Phase 2 Study of NGM282 in Patients With Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc
Collaborators
NGM Biopharmaceuticals Australia Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGM282 Dose 1
Arm Type
Experimental
Arm Description
NGM Dose 1
Arm Title
NGM282 Dose 2
Arm Type
Experimental
Arm Description
NGM Dose 2
Arm Title
NGM282 Dose 3
Arm Type
Experimental
Arm Description
NGM Dose 3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
NGM282
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Fasting Plasma Glucose
Time Frame
28 days
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
28 days
Title
Lipids
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Diagnosis of Type 1 diabetes History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex M DePaoli, MD
Organizational Affiliation
NGM Biopharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
NGM Clinical Study Site 6103
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site 6104
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site 6101
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
NGM Clinical Study Site 6403
City
Auckland
Country
New Zealand
Facility Name
NGM Clinical Study Site 6405
City
Auckland
Country
New Zealand
Facility Name
NGM Clinical Study Site 6401
City
Christchurch
Country
New Zealand
Facility Name
NGM Clinical Study Site 6406
City
Dunedin
Country
New Zealand
Facility Name
NGM Clinical Study Site 6404
City
Tauranga
Country
New Zealand
Facility Name
NGM Clinical Study Site 6402
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
30862680
Citation
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.
Results Reference
derived
Links:
URL
http://ngmbio.com/
Description
Related Info

Learn more about this trial

Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

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