RECRUITINGPhase 2INTERVENTIONAL
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Tesamorelin (GHRH Analog) for Reducing Hepatic Steatosis in Adults With Metabolic Associated Steatotic Liver Disease (MASLD)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Adults age 18 to 75 years, able to provide willing to sign a consent form.
- Evidence of hepatic steatosis consistent with MASLD/NAFLD, defined as MRI-PDFF \>=10% at screening (or equivalent imaging documentation if MRI-PDFF was performed within the prior 8 weeks).
- Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below a prespecified threshold and no clinical evidence of portal hypertension).
- Stable body weight (+/-5%) for at least 3 months prior to screening.
- If on diabetes, lipid-lowering, antihypertensive, or weight-loss medications, regimen is stable for at least 3 months prior to screening and expected to remain stable through week 52.
- Willingness and ability to self-administer daily subcutaneous injections (or have a trained caregiver).
- For participants of childbearing potential: agreement to use reliable contraception during treatment and for 30 days after the last dose; negative pregnancy test at screening and baseline.
Who Should NOT Join This Trial:
- Significant alcohol consumption consistent with alcohol-associated liver disease (e.g., \>20 g/day for women or \>30 g/day for men for sustained periods).
- Other chronic liver diseases (e.g., chronic hepatitis B, chronic hepatitis C with viremia, autoimmune hepatitis, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency).
- Known cirrhosis or decompensated liver disease; or biopsy-proven stage 4 fibrosis if baseline biopsy is performed.
- Poorly controlled diabetes or conditions increasing ocular risk (e.g., HbA1c at or above a protocol threshold; active/untreated diabetic retinopathy).
- Use of exogenous growth hormone or GHRH analogs within the past 12 months.
- Chronic systemic corticosteroids or chronic use of medications known to induce or worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate).
- Active malignancy or high risk for recurrence judged unsafe by investigators.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Adults age 18 to 75 years, able to provide informed consent.
* Evidence of hepatic steatosis consistent with MASLD/NAFLD, defined as MRI-PDFF \>=10% at screening (or equivalent imaging documentation if MRI-PDFF was performed within the prior 8 weeks).
* Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below a prespecified threshold and no clinical evidence of portal hypertension).
* Stable body weight (+/-5%) for at least 3 months prior to screening.
* If on diabetes, lipid-lowering, antihypertensive, or weight-loss medications, regimen is stable for at least 3 months prior to screening and expected to remain stable through week 52.
* Willingness and ability to self-administer daily subcutaneous injections (or have a trained caregiver).
* For participants of childbearing potential: agreement to use reliable contraception during treatment and for 30 days after the last dose; negative pregnancy test at screening and baseline.
Exclusion Criteria:
* Significant alcohol consumption consistent with alcohol-associated liver disease (e.g., \>20 g/day for women or \>30 g/day for men for sustained periods).
* Other chronic liver diseases (e.g., chronic hepatitis B, chronic hepatitis C with viremia, autoimmune hepatitis, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency).
* Known cirrhosis or decompensated liver disease; or biopsy-proven stage 4 fibrosis if baseline biopsy is performed.
* Poorly controlled diabetes or conditions increasing ocular risk (e.g., HbA1c at or above a protocol threshold; active/untreated diabetic retinopathy).
* Use of exogenous growth hormone or GHRH analogs within the past 12 months.
* Chronic systemic corticosteroids or chronic use of medications known to induce or worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate).
* Active malignancy or high risk for recurrence judged unsafe by investigators.
* Contraindications to MRI (e.g., certain implanted devices) if MRI-PDFF is required.
* Pregnancy or breastfeeding.
* Known hypersensitivity to tesamorelin or formulation excipients (e.g., mannitol).
* Bariatric surgery within the last 12 months, or planned bariatric surgery during the study period.
Treatments Being Tested
DRUG
Tesamorelin
for injection, 2 mg SC once daily; participant self-administration after training. Dose may be reduced to 1 mg daily if IGF-1 z-score meets protocol threshold.
DRUG
Placebo
for injection (mannitol-based, identical appearance), SC once daily.
BEHAVIORAL
Standardized lifestyle counseling
dietary guidance and physical activity recommendations,delivered at baseline and reinforced at each visit.
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China