Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) (ENLIVEN)

89bio

Status and phase: Completed; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: BIO89-100; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04929483

BIO89-100-122

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.

Enrollment: 222 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Age 21 to 75

• Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation.

  • Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period

Key Exclusion Criteria:

• Have poorly controlled high blood pressure
• Have type 1 diabetes or poorly controlled type 2 diabetes.
• History of cirrhosis or evidence of cirrhosis by clinical, imaging or liver biopsy evaluation
• Are planning to try to lose weight during the conduct of the study.
• Have a BMI <25 kg/m2

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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222 participants in 6 patient groups, including a placebo group

BIO89-100 - 15 mg once weekly (QW)

Experimental group

Description:

BIO89-100 - 15 mg QW

Treatment:

Drug: BIO89-100

BIO89-100 - 30 mg QW

Experimental group

Description:

BIO89-100 - 30 mg QW

Treatment:

Drug: BIO89-100

BIO89-100 - 44 mg once every 2 weeks (Q2W)

Experimental group

Description:

BIO89-100 - 44 mg Q2W

Treatment:

Drug: BIO89-100

Placebo QW

Placebo Comparator group

Description:

Placebo QW

Treatment:

Drug: Placebo

Placebo Q2W

Placebo Comparator group

Description:

Placebo Q2W

Treatment:

Drug: Placebo

Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)

Experimental group

Description:

Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)

Treatment:

Drug: Placebo

Drug: BIO89-100