Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Other: Placebo; Biological: NGM282

Study type: Interventional

Funder types: Industry

Identifiers

NCT01943045

13-0102

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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81 participants in 4 patient groups, including a placebo group

NGM282 Dose 1

Experimental group

Description:

NGM Dose 1

Treatment:

Biological: NGM282

NGM282 Dose 2

Experimental group

Description:

NGM Dose 2

Treatment:

Biological: NGM282

NGM282 Dose 3

Experimental group

Description:

NGM Dose 3

Treatment:

Biological: NGM282

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo