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Study of NGM395 in adult participants.
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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.
Primary purpose
Allocation
Interventional model
Masking
38 participants in 7 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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