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Study of NGM395 in adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGM395 Dose 1 | Experimental | NGM395 Subcutaneous Injection |
|
| NGM395 Dose 2 | Experimental | NGM395 Subcutaneous Injection |
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| NGM395 Dose 3 | Experimental | NGM395 Subcutaneous Injection |
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| NGM395 Dose 4 | Experimental | NGM395 Subcutaneous Injection |
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| NGM395 Dose 5 | Experimental | NGM395 Subcutaneous Injection |
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| NGM395 Dose 6 | Experimental | NGM395 Subcutaneous Injection |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM395 | Biological | NGM395 Dose 1 |
| |
| NGM395 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of NGM395 | NGM395 concentration data by cohort | 140 Days |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| NGM Study Director | NGM Biopharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site | Brisbane | Australia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo Comparator |
Placebo |
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| Biological |
NGM395 Dose 2 |
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| NGM395 | Biological | NGM395 Dose 3 |
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| NGM395 | Biological | NGM395 Dose 4 |
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| NGM395 | Biological | NGM395 Dose 5 |
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| NGM395 | Biological | NGM395 Dose 6 |
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| Placebo | Other | Placebo |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |