Study of NGM313 in Obese Participants

NGM Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Obese

Treatments: Biological: NGM313; Drug: Pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03298464

17-0202

Details and patient eligibility

About

The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants

Enrollment: 25 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) of 30-43 kg/m2
• Waist circumference > 40 inches in males or > 30 inches in females
• Normal ECG readings

Exclusion criteria

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
• History of any known Congestive heart failure (CHF)
• History of macrovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

NGM313

Experimental group

Treatment:

Biological: NGM313

Pioglitazone

Active Comparator group

Treatment:

Drug: Pioglitazone