Study of NGM395 in Adult Participants

Study Overview
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Brief Summary
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Study of NGM395 in adult participants.

Official Title
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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).

Conditions
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Obesity, NAFLD

Intervention / Treatment
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* Biological: NGM395
* Biological: NGM395
* Biological: NGM395
* Biological: NGM395
* Biological: NGM395
* Biological: NGM395
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part 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: Liver fat ≥8% as assessed by MRI-PDFF. BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening. Waist circumference > 40 inches for males or > 35 inches for females. Exclusion Criteria: Part 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. Subjects with T2D managed with diet alone with HbA1c level > 6.5% or fasting glucose ≥ 126 mg/dL at Screening. History of bariatric surgery. Fasting triglycerides > 400 mg/dL at Screening. Part 2: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM395 Dose 1<br>NGM395 Subcutaneous Injection | Biological: NGM395<br>* NGM395 Dose 1<br>|
| Experimental: NGM395 Dose 2<br>NGM395 Subcutaneous Injection | Biological: NGM395<br>* NGM395 Dose 2<br>|
| Experimental: NGM395 Dose 3<br>NGM395 Subcutaneous Injection | Biological: NGM395<br>* NGM395 Dose 3<br>|
| Experimental: NGM395 Dose 4<br>NGM395 Subcutaneous Injection | Biological: NGM395<br>* NGM395 Dose 4<br>|
| Experimental: NGM395 Dose 5<br>NGM395 Subcutaneous Injection | Biological: NGM395<br>* NGM395 Dose 5<br>|
| Experimental: NGM395 Dose 6<br>NGM395 Subcutaneous Injection | Biological: NGM395<br>* NGM395 Dose 6<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Concentration of NGM395 | NGM395 concentration data by cohort | 140 Days |