Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)

NCT07481734 | Recruiting Phase 2 DMC

• 1 other identifier: TESA-MASLD-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Associated Steatotic Liver Disease; Nonalcoholic Steatohepatitis; Hepatic Steatosis

Keywords

Tesamorelin; GHRH analog; growth hormone axis; hepatic fat fraction; MRI-PDFF; transient elastography; teatohepatitis; fibrosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points)

  MRI-PDFF performed at baseline and week 52; central blinded read.

  52 weeks

Secondary Outcomes (7)

• MRI-PDFF responder rate (>=30% relative decline from baseline)

  52 weeks

• Change in ALT

  52 weeks

• Change in liver stiffness by transient elastography

  52 weeks

• Change in controlled attenuation parameter (CAP) by transient elastography

  52 weeks

• Change in fasting glucose

  52 weeks

Study Arms (2)

Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I

EXPERIMENTAL

Drug: Tesamorelin; Drug: Placebo; Behavioral: Standardized lifestyle counseling

Placebo Comparator: Matching placebo subcutaneous once daily

EXPERIMENTAL

Drug: Tesamorelin; Drug: Placebo; Behavioral: Standardized lifestyle counseling

Interventions

Tesamorelin DRUG

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.

Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I; Placebo Comparator: Matching placebo subcutaneous once daily

Placebo DRUG

for injection (mannitol-based, identical appearance), SC once daily.

Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I; Placebo Comparator: Matching placebo subcutaneous once daily

Standardized lifestyle counseling BEHAVIORAL

dietary guidance and physical activity recommendations,delivered at baseline and reinforced at each visit.

Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I; Placebo Comparator: Matching placebo subcutaneous once daily

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hudson Biotech: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Fibrosis

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Seni S Lu, Phd

CONTACT

+86 13076790030; Seni-Lu@beijing-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Tesamorelin and placebo are identical in appearance and packaging. Randomization codes are held by an independent pharmacy. An unblinded endocrinology safety monitor may recommend protocol-defined dose reduction based on IGF-1 thresholds without revealing assignment to the study team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-arm, randomized, double-blind, placebo-controlled design. All participants receive standardized lifestyle counseling. Treatment duration is 52 weeks with 4-week post-treatment safety follow-up.

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 19, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 17, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)