Hepatitis D, ChronicPhase 3NCT07309380
Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
A Phase 3 study testing Hepalatide 2.1mg in people with Hepatitis D, Chronic, run by Shanghai HEP Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study adopts a multicenter, randomized, double-blind, placebo-parallel controlled design to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. A total of 150 subjects are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis D, Chronic
- What is being tested?
- Hepalatide 2.1mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jun 2027to Aug 2028
- Phase
- Phase 3
- 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
- Positive HBsAg or HBV DNA for at least 6 months (diagnosed as chronic hepatitis B), with stable nucleos(t)ide analogue (NA) treatment for ≥3 months prior to screening and documented HBV DNA suppression;
- Positive anti-HDV antibody (IgG and/or IgM) and at least two quantifiable HDV RNA measurements ≥3 months apart, with quantifiable HDV RNA at enrollment;
- 1×ULN< ALT<10×ULN；
- No plan for pregnancy within 2 years; female subjects must not be pregnant or lactating, and all subjects must agree to use effective contraception during treatment and for 3 months after the last dose;
- No participation in other clinical trials within 3 months prior to screening;
- Good compliance with the study protocol;
- Ability to understand and willingness to sign the informed consent form (ICF).
Who cannot join
- Child-Pugh class C or Child-Pugh score ≥10;
- Subjects with any of the following conditions:
- History of severe decompensated liver disease, including moderate to severe ascites (grade 2 or 3), hepatic encephalopathy, gastrointestinal variceal bleeding, hepatorenal syndrome, etc., with an expected survival of less than 2 years;
- History of severe cardiac disease (including unstable or uncontrolled heart disease within the past 6 months, or New York Heart Association [NYHA] functional class III-IV);
- Uncontrolled epilepsy, severe psychiatric disorders, or a history of severe psychiatric disorders;
- History of organ transplantation;
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- Diabetes mellitus or hypertension that is not adequately controlled;
- Presence of autoimmune diseases, immune-related extrahepatic manifestations (including vasculitis, purpura, polyarteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid diseases, malignancies, or receipt of immunosuppressive therapy;
- Presence of serious underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, or other serious diseases;
- History of alcohol abuse or drug addiction.
- Total bilirubin > 51 μmol/L, or serum albumin < 28 g/L, or prothrombin time prolonged by > 6 seconds;
- Creatinine clearance<60mL/min；
- Co-infection with hepatitis A, C, or E virus, or HIV infection;
- Use of interferon within 3 months prior to screening;
- Positive pregnancy test in female subjects;
- Abnormal hematology results: white blood cell count (WBC) < 3×10^9/L, neutrophil count 1.5×10^9/L, or platelet count 60×10^9/L；
- Current use of prohibited medications that cannot be discontinued;
- Use of L47 or Myrcludex B within 3 months prior to screening;
- Subjects receiving standardized nucleos(t)ide analogue (NA) therapy with a treatment duration of less than 12 weeks;
- Other significant abnormalities in laboratory tests or auxiliary examinations that, in the opinion of the investigator, make the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xian Gao contact
China1 site
First Hospital of Jilin University
Changchun, Jilin
Junqi Niu, 86-431-88782222, junqiniu@aliyun.com
About this study
Official title: Double-blinded Placebo-controlled Multi-center Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
This study adopts a multicenter, randomized, double-blind, placebo-parallel controlled design to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D.
A total of 150 subjects are planned to be enrolled. After passing the screening, they will be randomly assigned to the L47 group or the placebo group at a ratio of 2:1, with liver cirrhosis and subjects' regional distribution as stratification factors. The two groups will receive hepratide (2.1 mg/day) or placebo, respectively. Upon completion of the 48-week double-blind treatment phase, all subjects in each group can enter the open-label treatment follow-up phase, where they may voluntarily choose to receive L47 (2.1 mg/day) treatment or undergo follow-up observation only, until week 144.
Read more
Subjects who discontinue treatment prematurely during the trial may also enter the open-label treatment follow-up phase.
An interim analysis will be conducted after the subjects complete 24 weeks of trial treatment, with the comprehensive response rate at week 24 as the primary endpoint. The analysis will be performed by an independent statistical team. And the interim analysis results will be reviewed by the Independent Data Monitoring Committee (IDMC) .
All subjects will complete the 48-week double-blind clinical trial. Throughout the entire study period, the safety of subjects will be closely monitored and evaluated, including the monitoring of adverse events (AEs) and other safety indicators.
- Conditions
- Hepatitis D, Chronic
- Being tested
- Hepalatide 2.1mg, Placebo of Hepalatide
- Keywords
- hepalatide, L47
- Medical subject headings
- Hepatitis D, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepalatide 2.1mgDrug
Also called L47, HLT
Continuous treatment with hepalatide 2.1mg sc, qd, for 48 weeks
Placebo of HepalatideDrug
Continuous treatment with placebo of hepalatide for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | placebo of L47, sc,qd Receives: Drug: Placebo of Hepalatide |
| Group B | Experimental | hepalatide 2.1mg, sc, qd, Continuous treatment for 48 weeks Receives: Drug: Hepalatide 2.1mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieved response
HDV RNA suppression (< LLOQ) or a decrease of ≥ 2 log10 from baseline combined with ALT normalization
Measured: 48 weeks of treatment
Secondary outcomes (11)
Proportion of subjects with a ≥ 2 log₁₀ decrease in HDV RNA from baseline
Measured: 48 weeks of treatment
Proportion of subjects with a ≥ 2 log₁₀ decrease in HDV RNA from baseline and normalized ALT
Measured: Continuous treatment for 48 weeks
Proportion of subjects with HDV RNA below the limit of detection (LOD)
Measured: Continuous treatment for 48 weeks
Changes in HDV RNA relative to baseline
Measured: Continuous treatment for 48 weeks
Proportion of subjects with normalized ALT
Measured: Continuous treatment for 48 weeks
Changes in ALT relative to baseline
Measured: Continuous treatment for 48 weeks
Changes in HBV-related parameters (HBV DNA, HBeAg, qHBsAg, etc.)
Measured: Continuous treatment for 48 weeks
Changes in histological response of the liver
Measured: Continuous treatment for 48 weeks
Change in Model for End-Stage Liver Disease (MELD) score
Measured: Continuous treatment for 48 weeks
Change in Child-Turcotte-Pugh score
Measured: Continuous treatment for 48 weeks
Occurrence of liver-related endpoint events
such as cirrhosis, hepatic decompensation, HCC, liver transplantation / liver-related death, etc.
Measured: continuous treatment for 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study startJun 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis D, ChronicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai HEP Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, Professor, Study chair, The First Hospital of Jilin UniversityYanhang Gao, Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309380
- Sponsor's protocol ID
- L47-HD-II/III-01
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Placebo-controlled Multi-center Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
- ClinicalTrials.gov ID
- NCT07309380
- Acronym / sponsor ID
- L47-HD-II/III-01
- Conditions
- Hepatitis D, Chronic
- Keywords
- hepalatide, L47
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai HEP Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Dec 2025 (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 study adopts a multicenter, randomized, double-blind, placebo-parallel controlled design to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D.
A total of 150 subjects are planned to be enrolled. After passing the screening, they will be randomly assigned to the L47 group or the placebo group at a ratio of 2:1, with liver cirrhosis and subjects' regional distribution as stratification factors. The two groups will receive hepratide (2.1 mg/day) or placebo, respectively. Upon completion of the 48-week double-blind treatment phase, all subjects in each group can enter the open-label treatment follow-up phase, where they may voluntarily choose to receive L47 (2.1 mg/day) treatment or undergo follow-up observation only, until week 144.
Subjects who discontinue treatment prematurely during the trial may also enter the open-label treatment follow-up phase.
An interim analysis will be conducted after the subjects complete 24 weeks of trial treatment, with the comprehensive response rate at week 24 as the primary endpoint. The analysis will be performed by an independent statistical team. And the interim analysis results will be reviewed by the Independent Data Monitoring Committee (IDMC) .
All subjects will complete the 48-week double-blind clinical trial. Throughout the entire study period, the safety of subjects will be closely monitored and evaluated, including the monitoring of adverse events (AEs) and other safety indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: Placebo of Hepalatideplacebo of L47, sc,qd |
| Group B | Experimental | Drug: Hepalatide 2.1mghepalatide 2.1mg, sc, qd, Continuous treatment for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Positive HBsAg or HBV DNA for at least 6 months (diagnosed as chronic hepatitis B), with stable nucleos(t)ide analogue (NA) treatment for ≥3 months prior to screening and documented HBV DNA suppression;
- Positive anti-HDV antibody (IgG and/or IgM) and at least two quantifiable HDV RNA measurements ≥3 months apart, with quantifiable HDV RNA at enrollment;
- 1×ULN< ALT<10×ULN；
- No plan for pregnancy within 2 years; female subjects must not be pregnant or lactating, and all subjects must agree to use effective contraception during treatment and for 3 months after the last dose;
- No participation in other clinical trials within 3 months prior to screening;
Key exclusion criteria (20 listed)
- Child-Pugh class C or Child-Pugh score ≥10;
- Subjects with any of the following conditions:
- Total bilirubin > 51 μmol/L, or serum albumin < 28 g/L, or prothrombin time prolonged by > 6 seconds;
- Creatinine clearance<60mL/min；
- Co-infection with hepatitis A, C, or E virus, or HIV infection;
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 |
|---|---|---|
| Hepalatide 2.1mgAlso: L47, HLTContinuous treatment with hepalatide 2.1mg sc, qd, for 48 weeks | Drug | Group B |
| Placebo of HepalatideContinuous treatment with placebo of hepalatide for 48 weeks | Drug | Group A |
Primary outcome
Proportion of subjects who achieved response
Time frame: 48 weeks of treatment
HDV RNA suppression (< LLOQ) or a decrease of ≥ 2 log10 from baseline combined with ALT normalization
11 secondary outcomes
Proportion of subjects with a ≥ 2 log₁₀ decrease in HDV RNA from baseline
Time frame: 48 weeks of treatment
Proportion of subjects with a ≥ 2 log₁₀ decrease in HDV RNA from baseline and normalized ALT
Time frame: Continuous treatment for 48 weeks
Proportion of subjects with HDV RNA below the limit of detection (LOD)
Time frame: Continuous treatment for 48 weeks
Changes in HDV RNA relative to baseline
Time frame: Continuous treatment for 48 weeks
Proportion of subjects with normalized ALT
Time frame: Continuous treatment for 48 weeks
Changes in ALT relative to baseline
Time frame: Continuous treatment for 48 weeks
Changes in HBV-related parameters (HBV DNA, HBeAg, qHBsAg, etc.)
Time frame: Continuous treatment for 48 weeks
Changes in histological response of the liver
Time frame: Continuous treatment for 48 weeks
Change in Model for End-Stage Liver Disease (MELD) score
Time frame: Continuous treatment for 48 weeks
Change in Child-Turcotte-Pugh score
Time frame: Continuous treatment for 48 weeks
Occurrence of liver-related endpoint events
Time frame: continuous treatment for 48 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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Xian Gao contact
Junqi Niu, Professor study chair
The First Hospital of Jilin University
Yanhang Gao study chair
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hepalatide 2.1mg in people with Hepatitis D, Chronic, run by Shanghai HEP Pharmaceutical Co., Ltd. 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 20 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: opening soon, as of the sponsor's last update on 28 Oct 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiaolu Tang (86-21-68412368, tangxiaolu@heppharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who achieved response (time frame: 48 weeks of treatment). 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 28 Oct 2026.