HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes (CENTRICITY)

HighTide Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Nonalcoholic Steatohepatitis (NASH); Type 2 Diabetes

Treatments: Drug: Placebo; Drug: HTD1801

Study type: Interventional

Funder types: Industry

Identifiers

NCT05623189

HTD1801.PCT014

The CENTRICITY Study (Other Identifier)

Details and patient eligibility

About

A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.

Full description

This phase 2b, double-blind, randomized, placebo-controlled, multicenter study will evaluate the effect of HTD1801, 1250 mg twice daily (BID) compared to placebo BID on histologic improvements in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.

The study will enroll approximately 210 subjects with biopsy-confirmed non-alcoholic steatohepatitis and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive investigational product for up to 60 weeks.

Enrollment: 218 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion criteria:

• Clinical diagnosis of non-alcoholic steatohepatitis (NASH) upon central read of a liver biopsy obtained no more than 6 months before Day 0.
• Histologic evidence of fibrosis stage 2 or stage 3 as defined by the non-alcoholic steatohepatitis (NASH) clinical research network (CRN) scoring of fibrosis.
• Clinically documented diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening or prediabetes at screening.
• BMI >25 kilograms/meters squared (>23 kilograms/meters squared if Asian).

Key Exclusion criteria:

• Fibrosis stage 4.
• History of alcohol or substance abuse or dependence.
• Liver disease unrelated to non-alcoholic steatohepatitis.
• History of significant cardiovascular disease.
• History of type 1 diabetes.
• Inability or unwillingness to undergo 2 planned liver biopsies OR 1 planned biopsy if historical liver biopsy was used to confirm eligibility at entry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups, including a placebo group

HTD1801

Experimental group

Description:

HTD1801,1250 mg, BID

Treatment:

Drug: HTD1801

placebo

Placebo Comparator group

Description:

placebo, BID

Treatment:

Drug: Placebo