Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

Melinta Therapeutics

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: solithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02510599

CE01-205

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.

Full description

Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic evidence of NASH based on liver biopsy obtained within 180 days
• NAS> or = 5
• Able to swallow capsules intact

Exclusion criteria

• Symptoms of acute liver disease
• Cirrhosis on liver biopsy
• Positive HIV or Hepatitis tests
• Primary Biliary Cirrhosis
• Poorly controlled diabetes with HgA1C >8.5%
• ALT >4-fold upper limit of normal
• QTcF >450 msec
• CrCl <40 mL/min

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Solithromycin

Experimental group

Description:

Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks

Treatment:

Drug: solithromycin