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Hepatitis DPhase 2L47-HD-MNNCT06505928

A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D

A Phase 2 study testing hepalatide in people with Hepatitis D, run by Shanghai HEP Pharmaceutical Co., Ltd. at 2 sites in Mongolia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into three groups at a 1:1:1 ratio. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis D
What is being tested?
hepalatide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesMongolia
Study dates
11 Dec 2024to Jul 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Male or female subjects aged 18-65 years (both inclusive);
  • 2. Subjects with positive HBsAg and/or HBV DNA for at least 6 months ("CHB");
  • 3. Subjects with positive serum anti-HDV antibody before or at screening or with positive HDV RNA for at least 6 months before screening ("CHD");
  • 4. Subjects with positive and quantifiable HDV RNA before enrollment;
  • 5. 1 × ULN < ALT < 10 × ULN;
  • 6. Subjects who should be treated with nucleoside/nucleotide reverse transcriptase inhibitors at enrollment or after enrollment according to the guidelines for the treatment of hepatitis D (compensated cirrhosis with detectable HBV DNA, or HBV DNA > 2000 IU/mL in patients without cirrhosis) and consent to the use of entecavir for the treatment of chronic hepatitis B;
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  • 7. Subjects who do not plan a pregnancy within 3 years (women who are not pregnant or lactating, and males who agree to take effective contraceptive measures throughout the treatment period and for 3 months after the last dose);
  • 8. Subjects exhibiting good compliance to the study protocol;
  • 9. Subjects who understand the ICF and agree to sign it.

Who cannot join

  • 1. Subjects suffering from severe decompensated liver fibrosis or decompensated liver cirrhosis with a Child-Pugh score > 7;
  • 2. Decompensated liver disease: Direct bilirubin > 1.2 x ULN or prothrombin time > 1.2 x ULN or serum albumin < 35 g/L;
  • 3. Abnormal hematology findings: White blood cell count (WBC) < 3 × 109/L, neutrophil count < 1.5 × 109/L or platelet count < 60 × 109/L;
  • 4. Creatinine clearance < 60 mL/min;
  • 5. Subjects who have any of the following conditions:
  • History of current or past decompensated liver diseases (including coagulopathy, hepatic encephalopathy, and variceal bleeding);
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  • Comorbidity of underlying diseases such as severe infection, heart failure and chronic obstructive pulmonary disease, and other severe diseases;
  • Diabetes mellitus and hypertension not effectively controlled (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg);
  • Current or previous uncontrolled epilepsy or psychiatric disorders;
  • History of solid organ transplantation;
  • Evidence of active or suspected malignancies or history of malignancies, or untreated premalignant lesions within the past 5 years (except for successfully treated cervical carcinoma in situ at least 1 year before screening, and successfully treated basal cell carcinoma and squamous cell carcinoma [≤ 3 cases of resected skin cancer within 5 years before screening ]), or history of liver cancer;
  • History of alcohol abuse or drug addiction at present or within 6 months prior to participation in this study; 6. Subjects co-infected with hepatitis A, C, or E virus or with uncontrolled HIV co-infection (those with positive HCV antibody but negative HCV RNA at screening are eligible for enrollment. HIV-infected patients may be enrolled if cluster of differentiation 4 (CD4) cell count is > 500/mL and HIV RNA is below the limit of detection for at least 12 months);
  • 7. Presence of one or more other known primary or secondary liver diseases, such as alcoholism, autoimmune hepatitis, malignancies involving the liver, hemochromatosis, other congenital or metabolic diseases affecting the liver, congestive heart failure, or other serious cardiopulmonary diseases, excluding hepatitis B;
  • 8. Subjects with one or more autoimmune diseases, immune-related extrahepatic manifestations (such as vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), or a history of requiring regular use of systemic corticosteroids (inhaled corticosteroids are allowed) or other immunosuppressive agents;
  • 9. Subjects who have used interferon within 6 months before screening;
  • 10. Subjects who have used L47 or Bulevirtide within 3 months;
  • 11. Allergy to entecavir;
  • 12. Pregnant or breastfeeding women;
  • 13. Subjects who participated in other drug clinical trials within 30 days before randomization;
  • 14. Subjects who are receiving prohibited treatment at screening that cannot be discontinued;
  • 15. Subjects who cannot comply with the study protocol and complete all procedures as scheduled, or have significant abnormalities in other laboratory or auxiliary examinations, which render them ineligible for this trial.

Trial locations and contacts

2 sites in 1 country.

Mongolia2 sites

  • National cancer canter of Monglia

    Ulaanbaatar, 13370

  • National Center for Communicable Diseases

    Ulaanbaatar

Other trials in Mongolia

About this study

Official title: A Parallel-group, Randomized, Open-label Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D.

The goal of this clinical trial is to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into three groups at a 1:1:1 ratio. The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). Primary endpoint evaluation will be performed after the subjects complete the 48-week treatment.

Read the detailed description

This is a three-arm, parallel-group, randomized, open-label, delayed-controlled phase IIb clinical trial. The study flow chart is shown in Fig. 1.2.1. CHD patients with compensated liver function who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into the 2.1 mg group, 4.2 mg group, and delayed treatment group at a 1:1:1 ratio (Table 1.1). The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). The 1st interim analysis will be performed when all subjects complete the Week12 visit to determine the optimal dose for the extended treatment period following the trial. The 2nd interim analysis will be performed when all subjects complete the Week24 visit. Upon completion of the 48th week of treatment, the primary endpoint was assessed, and the trial was officially concluded.

After the conclusion of the trial, all subjects in each group entered the extension treatment period and were all treated continuously with the L47 optimal dose for 96 weeks. After the extension treatment ended, all groups discontinued the medication and were observed for 48 weeks follow-up.

Conditions
Hepatitis D
Being tested
hepalatide
Medical subject headings
Hepatitis D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hepalatideDrug

    Also called L47

    hepalatide of 2.1 mg/d or 4.2mg/d s.c. treatment for 48 weeks

Study groups in NCT06505928
Study groupRoleWhat they receive
Hepalatide 2.1mgExperimentalhepalatide 2.1mg/d, s.c. for 48 weeks
Receives: Drug: hepalatide
Hepalatide 4.2mgExperimentalhepalatide 4.2mg/d, s.c. for 48 weeks
Receives: Drug: hepalatide
delayed treatment groupsNo interventiondelayed treatment for 48 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. compound response

    Decrease in HDV RNV by ≥ 2 log10 from baseline and ALT normalization

    Measured: Week 48

Secondary outcomes (10)

  1. HDV RNA below LLOQ

    The incidence of subjects with HDV RNA lower than LLOQ.

    Measured: Week 48

  2. Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA

    The incidence of subjects with Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA

    Measured: Week 48

  3. Decrease in HDV RNA from baseline

    HDV RNA reduction from baseline.

    Measured: Week 48

  4. ALT normalization

    The rate of ALT relapse in subjects.

    Measured: Week 48

  5. Decrease in ALT from baseline

    ALT reduction from baseline.

    Measured: Week 48

  6. Changes in subjects' METAVIR system scores from baseline.

    The METAVIR score is a test used to determine the degree of inflammation and necrosis in the liver biopsy, as well as the extent of fibrosis. The degree of liver fibrosis is divided into five grades from F 0 to F4. The degree of inflammatory activity in liver tissue is divided into four grades from A0 to A3. Higher score means worse outcome.

    When the liver tissue inflammation and necrosis score decreased by ≥2 points compared with baseline (the change of inflammatory activity A value compared with baseline was ≤ -2 points), and there was no increase in liver fibrosis score; Or the liver fibrosis score decreased by ≥1 point (fibrosis stage F value change from baseline ≤ 0 points)，it means Liver tissue response.

    Measured: Week 48

  7. Change in fibrosis 4 (FIB-4) index from baseline

    Fibrosis 4（FIB-4）Index is a non-invasive method for assessing liver fibrosis in patients with chronic liver disease. The FIB-4 index is <1.45, indicating no significant liver fibrosis or only 2nd degree or lower liver fibrosis. And the FIB-4 index>3.25 indicates that the degree of liver fibrosis is 3-4 or higher.

    Measured: Week 48

  8. Change in Child-Pugh score from baseline

    Child-Pugh scores is a test that determines the scope and severity of liver failure as well as the prognosis for the patient. Three categories "A, B and C " indicate the severity of liver breakdown on the Child-Pugh rating scale. The higher the scale, the more serious outcomes.

    Measured: Week 48

  9. Change in Model for End-Stage Liver Disease (MELD) score from baseline

    R = 9.6 \* ln(serum creatinine in mg/dl) + 3.8 \* ln(bilirubin in mg/dl) + 11.2 \* ln(INR) + 6.4 \* cause (cause: cholestasis and alcoholic cirrhosis = 0, viral and other causes of cirrhosis = 1). The higher the R value, the greater the risk, and the lower the survival rate.

    Measured: Week 48

  10. The incidence rate of Liver-related endpoint events.

    The incidence of Liver-related endpoint events such as cirrhosis, hepatic decompensation, HCC, liver transplantation, liver-related death.

    Measured: Week 240

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study start11 Dec 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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
This is a three-arm, parallel-group, randomized, open-label, delayed-controlled phase IIb clinical trial.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06505928
Sponsor's protocol ID
L47-HD-MN
Acronym
L47-HD-MN
Status last verified
Dec 2025
First submitted
10 Jul 2024
Last updated
23 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hepalatide in people with Hepatitis D, run by Shanghai HEP Pharmaceutical Co., Ltd. at 2 sites in Mongolia.

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 9 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mongolia. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compound response (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06505928.

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 23 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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