Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07481734
Brief Summary:
This randomized, double-blind, placebo-controlled Phase II study evaluates whether daily subcutaneous tesamorelin (a growth hormone-releasing hormone analog) reduces liver fat in adults with fatty liver disease. Participants receive tesamorelin or matching placebo for 52 weeks, with standardized lifestyle counseling in both groups. Liver fat is quantified by MRI-proton density fat fraction (MRI-PDFF). Key safety monitoring includes glucose metrics and IGF-1.
Detailed Description:
Fatty liver disease (MASLD/NAFLD) is common and may progress to steatohepatitis and fibrosis. There are limited pharmacologic options that directly and durably reduce hepatic steatosis while also improving metabolic risk. Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH) that increases endogenous pulsatile growth hormone secretion and can influence lipid metabolism. Prior randomized studies of tesamorelin have shown reductions in hepatic fat fraction in populations with NAFLD, using magnetic-resonance-based quantification and paired histology in subsets. The primary efficacy endpoint is change in liver fat (MRI-PDFF) from baseline to week 52. Secondary endpoints include MRI-PDFF responder rate (\>=30% relative decline), changes in liver enzymes and noninvasive fibrosis measures, metabolic outcomes (glucose, HbA1c, HOMA-IR, lipids), and safety/tolerability outcomes. In this mock protocol, eligible adults with elevated liver fat on MRI-PDFF are randomized 1:1 to tesamorelin or placebo. Study medication is self-administered once daily by subcutaneous injection.
Dose reduction rules are included for elevated IGF-1 while preserving the blind.
Participants complete study visits at baseline and at weeks 4, 12, 24, 36, and 52 (end of treatment), plus a safety follow-up at week 56. MRI-PDFF is performed at baseline, week 24, and week 52. Transient elastography (FibroScan) and standard laboratory panels are collected at prespecified visits. A voluntary liver-biopsy sub-study is offered to evaluate histologic activity and fibrosis.
Study:
NCT07481734
Study Brief:
Protocol Section:
NCT07481734