The trial is taking place at:
P

Palmetto Clinical Research | Summerville, SC

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

H

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

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

Trial contacts and locations

55

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Central trial contact

Cathryn Bennett, BN, RN, CCRA

Data sourced from clinicaltrials.gov

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