NCT02708576

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

February 29, 2016

Last Update Submit

September 13, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Absolute change in weight in kilograms

    28 and 84 days

Secondary Outcomes (1)

  • Absolute change in fasting glucose in mmol/L

    28 and 84 days

Other Outcomes (4)

  • Safety and tolerability as measured by adverse events, vitals signs, electrocardiograms, and clinical laboratories

    28 and 84 days

  • Pharmacokinetics as measured by maximum observed concentration (cmax).

    28 and 84 days

  • Pharmacokinetics as measured by time to maximum concentration (tmax).

    28 and 84 days

  • +1 more other outcomes

Study Arms (2)

NGM313

EXPERIMENTAL

Administration of active NGM313

Biological: NGM313

Placebo

PLACEBO COMPARATOR

Administration of placebo comparator

Other: Placebo

Interventions

NGM313BIOLOGICAL
NGM313
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NGM Clinical Study Site

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Que Liu, MD

    NGM Biopharmaceuticals, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 15, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)