Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

NCT ID: NCT01943045

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NGM282 Dose 1

NGM Dose 1

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

NGM282 Dose 2

NGM Dose 2

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

NGM282 Dose 3

NGM Dose 3

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NGM Biopharmaceuticals Australia Pty Ltd

INDUSTRY

Sponsor Role collaborator

NGM Biopharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex M DePaoli, MD

Role: STUDY_DIRECTOR

NGM Biopharmaceuticals, Inc

Locations

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NGM Clinical Study Site 6103

Melbourne, Victoria, Australia

Site Status

NGM Clinical Study Site 6104

Melbourne, Victoria, Australia

Site Status

NGM Clinical Study Site 6101

Perth, Western Australia, Australia

Site Status

NGM Clinical Study Site 6403

Auckland, , New Zealand

Site Status

NGM Clinical Study Site 6405

Auckland, , New Zealand

Site Status

NGM Clinical Study Site 6401

Christchurch, , New Zealand

Site Status

NGM Clinical Study Site 6406

Dunedin, , New Zealand

Site Status

NGM Clinical Study Site 6404

Tauranga, , New Zealand

Site Status

NGM Clinical Study Site 6402

Wellington, , New Zealand

Site Status

Countries

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Australia New Zealand

References

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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.

Reference Type DERIVED
PMID: 30862680 (View on PubMed)

Related Links

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Other Identifiers

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13-0102

Identifier Type: -

Identifier Source: org_study_id