Phase 1 Study of NGM313 in Healthy Adult Participants

NGM Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Biological: NGM313; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02708576

15-0201

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability of NGM313, both single dose and multiple doses, in normal healthy overweight and obese adult participants.

Enrollment: 151 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI range 27-40 kg/m2, inclusive for the SAD module, and 27-40 kg/m2, inclusive for the MAD module;
• Normal clinical laboratory evaluations
• Normal ECG findings

Exclusion criteria

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
• Uncontrolled hypertension defined as sitting blood pressure systolic > 150 mm/Hg and/or diastolic > 90 mm/Hg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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151 participants in 2 patient groups, including a placebo group

NGM313

Experimental group

Description:

Administration of active NGM313

Treatment:

Biological: NGM313

Placebo

Placebo Comparator group

Description:

Administration of placebo comparator

Treatment:

Other: Placebo