Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)

Second Genome

Status and phase: Terminated; Phase 2

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: SGM-1019

Study type: Interventional

Funder types: Industry

Identifiers

NCT03676231

SGM-1019-102

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Age 18 to 75 years, inclusive
• Elevated ALT
• F1-F3 NASH
• BMI ≥ 25

Exclusion criteria

• Use of prohibited medication/supplements
• Poorly controlled type 2 diabetes
• Hepatic decompensation
• Chronic liver disease
• Planned surgeries/procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 3 patient groups, including a placebo group

High-dose SGM-1019

Experimental group

Treatment:

Drug: SGM-1019

Low-dose SGM-1019

Experimental group

Treatment:

Drug: SGM-1019

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo