Metabolic Associated Steatotic Liver DiseasePhase 2TESA-LIVERNCT07481734
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
A Phase 2 study testing Tesamorelin and Standardized lifestyle counseling in people with Metabolic Associated Steatotic Liver Disease and Nonalcoholic Steatohepatitis, run by Hudson Biotech at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, Hepatic Steatosis
- What is being tested?
- Tesamorelin and Standardized lifestyle counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 17 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, Hepatic Steatosis
- Being tested
- Tesamorelin, Placebo, Standardized lifestyle counseling
- Keywords
- Tesamorelin, GHRH analog, growth hormone axis, hepatic fat fraction, MRI-PDFF, transient elastography, teatohepatitis, fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesamorelinDrug
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.
PlaceboDrug
for injection (mannitol-based, identical appearance), SC once daily.
Standardized lifestyle counselingBehavioural
dietary guidance and physical activity recommendations,delivered at baseline and reinforced at each visit.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I | Experimental | Not described Receives: Drug: Tesamorelin; Drug: Placebo; Behavioral: Standardized lifestyle counseling |
| Placebo Comparator: Matching placebo subcutaneous once daily | Experimental | Not described Receives: Drug: Tesamorelin; Drug: Placebo; Behavioral: Standardized lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points)
MRI-PDFF performed at baseline and week 52; central blinded read.
Measured: 52 weeks
Secondary outcomes (7)
MRI-PDFF responder rate (>=30% relative decline from baseline)
Responder analysis using MRI-PDFF values (baseline vs week 52).
Measured: 52 weeks
Change in ALT
Clinical chemistry panel at baseline and scheduled visits.
Measured: 52 weeks
Change in liver stiffness by transient elastography
FibroScan liver stiffness measurement; performed per site SOP.
Measured: 52 weeks
Change in controlled attenuation parameter (CAP) by transient elastography
FibroScan CAP measurement
Measured: 52 weeks
Change in fasting glucose
Measured: 52 weeks
Change in fasting lipids
Measured: 52 weeks
Change in visceral adipose tissue (VAT) volume
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start2 Feb 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion17 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hudson Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481734
- Sponsor's protocol ID
- TESA-MASLD-201
- Acronym
- TESA-LIVER
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07481734
- Acronym / sponsor ID
- TESA-LIVER / TESA-MASLD-201
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hudson BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 17 Feb 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tesamorelinfor 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 | Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I, Placebo Comparator: Matching placebo subcutaneous once daily |
| Placebofor injection (mannitol-based, identical appearance), SC once daily. | Drug | Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I, Placebo Comparator: Matching placebo subcutaneous once daily |
| Standardized lifestyle counselingdietary guidance and physical activity recommendations,delivered at baseline and reinforced at each visit. | Behavioural | Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I, Placebo Comparator: Matching placebo subcutaneous once daily |
Primary outcome
Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points)
Time frame: 52 weeks
MRI-PDFF performed at baseline and week 52; central blinded read.
7 secondary outcomes
MRI-PDFF responder rate (>=30% relative decline from baseline)
Time frame: 52 weeks
Change in ALT
Time frame: 52 weeks
Change in liver stiffness by transient elastography
Time frame: 52 weeks
Change in controlled attenuation parameter (CAP) by transient elastography
Time frame: 52 weeks
Change in fasting glucose
Time frame: 52 weeks
Change in fasting lipids
Time frame: 52 weeks
Change in visceral adipose tissue (VAT) volume
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesamorelin and Standardized lifestyle counseling in people with Metabolic Associated Steatotic Liver Disease and Nonalcoholic Steatohepatitis, run by Hudson Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.