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Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

N

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

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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