Study of NGM395 in Adult Participants

Obesity Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-controlled, Double-blind, Two-part Study to Evaluate the Safety and Tolerability of NGM395 in Adult Obese Patients (Part 1) and in Adult Patients With Nonalcoholic Fatty Liver Disease (NAFLD) (Part 2).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187339
• Other study ID #: NGM395-OB-101
• Status: Completed
• Phase: Phase 1
• Start date: February 13, 2020
• Est. completion date: April 22, 2021

Study information

• Verified date: July 2021
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of NGM395 in adult participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 22, 2021
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Part 1:

1. Body mass index (BMI) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg.

Part 2:

2. Liver fat =8% as assessed by MRI-PDFF.

3. BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.

4. Waist circumference > 40 inches for males or > 35 inches for females.

Exclusion Criteria:

Part 1:

1. Diagnosed with type 2 diabetes (T2D) and/or the use of metformin, dipeptidyl peptidase-4 (DPP4) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, sulfonylurea agents, acarbose, or insulin for T2D within 3 months prior to Screening.

2. Subjects with T2D managed with diet alone with HbA1c level > 6.5% or fasting glucose = 126 mg/dL at Screening.

3. History of bariatric surgery.

4. Fasting triglycerides > 400 mg/dL at Screening.

Part 2:

5. Diagnosed with type 2 diabetes with a HbA1c >9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (SGLT2) inhibitors, acarbose, or insulin for T2D within 3 months prior to Screening.

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

Biological:
• NGM395
NGM395 Dose 1
• NGM395
NGM395 Dose 2
• NGM395
NGM395 Dose 3
• NGM395
NGM395 Dose 4
• NGM395
NGM395 Dose 5
• NGM395
NGM395 Dose 6

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	NGM Clinical Study Site	Brisbane

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)	The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.	140 Days
Secondary	Serum Concentration of NGM395	NGM395 concentration data by cohort	140 Days