Phase 1 Study of NGM313 in Healthy Adult Participants

Obesity Clinical Trial

Official title:

A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM313 in Healthy Overweight and Obese Adult Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708576
• Other study ID #: 15-0201
• Status: Completed
• Phase: Phase 1
• First received: February 29, 2016
• Last updated: September 13, 2017
• Start date: February 2016
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Biological:
• NGM313

Other:
• Placebo

Locations

Country	Name	City	State
Australia	NGM Clinical Study Site	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability as measured by adverse events, vitals signs, electrocardiograms, and clinical laboratories		28 and 84 days
Other	Pharmacokinetics as measured by maximum observed concentration (cmax).		28 and 84 days
Other	Pharmacokinetics as measured by time to maximum concentration (tmax).		28 and 84 days
Other	Pharmacokinetics as measured by area under the curve (auc).		28 and 84 days
Primary	Absolute change in weight in kilograms		28 and 84 days
Secondary	Absolute change in fasting glucose in mmol/L		28 and 84 days