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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis

Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis (NCT07192939) is a Phase 2 interventional studying IPF and PPF, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against IPF and PPF and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 270 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused IPF and PPF subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. willing to sign a consent form was obtained to participate in the trial 2. Patients were aged ≥21 years for PPF and ≥45 years for IPF. 3. IPF diagnosed within 7 years before screening (including the screening period) or evidence of progressive ILD within 12 months before screening; 4. HRCT and surgical lung biopsy or transbronchial lung cryobiopsy, when available, support the clinical diagnosis; 5. The central HRCT reading results of PPF at screening showed that the whole lung parenchymal fibrosis was \> 10%; 6. Treatment with nintedanib or pirfenidone was discontinued at least 8 weeks before screening or was stabilized for at least 8 weeks; 7. FVC as a percentage of normal predicted value ≥40%; 8. DLCO SB (Hb corrected) as a percentage of normal predicted value ≥25%; 9. Female subjects of childbearing potential must have a negative pregnancy test before the first dose of medication. And must be non-lactating. Female subjects of childbearing potential or male subjects whose partner is a female of childbearing potential agree to be infertile, have a sperm/egg donation plan, and voluntarily use highly effective contraception (including their partner) from the time they sign ICF until 14 days after the last dose of medication, which is the end of safety follow-up. Who Should NOT Join This Trial: 1. IPF cohort: i. Interstitial lung disease (ILD) of other known cause; ii. Diagnosis of sarcoidosis or any systemic autoimmune conditions (where your immune system attacks your own body); 2. PPF cohort: IPF diagnosis and UIP features supported by HRCT central reading, surgical lung biopsy, or cryobiopsy pathology. 3. The presence of emphysema of 50% or more on centrally read HRCT or the degree of emphysema greater than the degree of fibrosis on the basis of the most recent HRCT report. 4. The presence of clinically significant nonsubstantial lung disease was considered by the investigator to be likely to affect the assessment of the study. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Informed consent was obtained to participate in the trial 2. Patients were aged ≥21 years for PPF and ≥45 years for IPF. 3. IPF diagnosed within 7 years before screening (including the screening period) or evidence of progressive ILD within 12 months before screening; 4. HRCT and surgical lung biopsy or transbronchial lung cryobiopsy, when available, support the clinical diagnosis; 5. The central HRCT reading results of PPF at screening showed that the whole lung parenchymal fibrosis was \> 10%; 6. Treatment with nintedanib or pirfenidone was discontinued at least 8 weeks before screening or was stabilized for at least 8 weeks; 7. FVC as a percentage of normal predicted value ≥40%; 8. DLCO SB (Hb corrected) as a percentage of normal predicted value ≥25%; 9. Female subjects of childbearing potential must have a negative pregnancy test before the first dose of medication. And must be non-lactating. Female subjects of childbearing potential or male subjects whose partner is a female of childbearing potential agree to be infertile, have a sperm/egg donation plan, and voluntarily use highly effective contraception (including their partner) from the time they sign ICF until 14 days after the last dose of medication, which is the end of safety follow-up. Exclusion Criteria: 1. IPF cohort: i. Interstitial lung disease (ILD) of other known cause; ii. Diagnosis of sarcoidosis or any systemic autoimmune disease; 2. PPF cohort: IPF diagnosis and UIP features supported by HRCT central reading, surgical lung biopsy, or cryobiopsy pathology. 3. The presence of emphysema of 50% or more on centrally read HRCT or the degree of emphysema greater than the degree of fibrosis on the basis of the most recent HRCT report. 4. The presence of clinically significant nonsubstantial lung disease was considered by the investigator to be likely to affect the assessment of the study. 5. Subjects were known to have pulmonary hypertension requiring treatment with multiple medications. 6. Active tuberculosis infection within 12 months before and/or during screening, or lower respiratory tract infection requiring antibiotic treatment within 4 weeks before and/or during screening, or evidence of active infection on clinical and laboratory tests at the screening/baseline visit. 7. Acute exacerbations of IPF/ILD occurred within 12 weeks before and/or during screening. 8. A history of unstable or worsening cardiac disease within 6 months before screening 9. Uncontrolled atrial or ventricular arrhythmias or the known presence of significant left ventricular dysfunction. 10. A cerebrovascular event leading to hospitalization had occurred within 6 months before screening 11. Had a history of lung volume reduction surgery or transplant, were awaiting lung transplant, or were scheduled to undergo lung volume reduction surgery or transplant during the study period. 12. Subjects with a history of malignancy within the previous 5 years, or a suspicion of malignancy on biopsy, and those for whom the possibility of malignancy could not be reasonably ruled out after additional clinical, laboratory, or other diagnostic evaluation were screened. 13. The patients were positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) at the time of screening. A test for antibodies to the human immunodeficiency virus (HIV) was not negative at screening. 14. A history of smoking (including e-cigarettes) within 3 months before screening or an unwillingness to quit smoking during the study. 15. Regular alcohol consumption in the 6 months before screening or an unwillingness to reduce alcohol consumption to less than 21 units during the study. 16. He had a history of substance abuse within 6 months before screening. 17. Pregnant or breastfeeding. 18. Treatment with prednisone at a dose of more than 15 mg per day or another systemic glucocorticoid at the equivalent dose was received within 4 weeks before screening and during the study. 19. Use of an IL-6 inhibitor within 3 months before screening and planned use during the study. 20. Disease-modifying antirheumatic drugs or a change in dose were initiated within 3 months before screening. 21. Initiation of mycophenolate mofetil, mycophenolic acid, azathioprine, tacrolimus, methotrexate, leflunomide, or a change in the dose of the above drugs within 3 months before screening; Immunosuppressive drugs could not be started during the treatment phase. 22. Rituximab was used 6 months before screening and was planned for the duration of the study. 23. Participants who had used a potent inhibitor or inducer of cytochrome P450(CYP)3A4 within 4 weeks before randomization or who had to be treated with or planned to be treated with a drug ban during the study. 24. Persons who had participated in a clinical trial of any drug or device within 1 month before screening and who had expected legacy effects of the trial treatment (at the discretion of the investigator) or who were within the follow-up period of a clinical study or the five half-lives of the trial drug before screening. 25. Major surgery (surgery under general anesthesia) that was performed within 3 months before screening or that was planned during the study that, as assessed by the investigator, would affect the determination of the end points. 26. Uncontrolled hypertension was present before screening or randomization. 27. Patients with orthostatic intolerance, orthostatic hypotension, or orthostatic tachycardia, as well as patients with a previous history of these conditions, at screening or before randomization. 28. A history of persistent or active syncope after urination/defecation, a previous known history of syncope, or a concomitant medical condition that increases the risk of syncope. 29. Bilirubin, transaminase, blood routine and other abnormalities exceed the requirements during screening. 30. An electrocardiogram showed a heart rate of less than 55 beats per minute before screening or randomization or a QT interval of at least 500 msec or a QTcF interval of at least 450 msec before randomization. 31. Allergy to drugs in the same class or to any component of HRS-9813. 32. Other reasons for not participating in the study as judged by the investigator.

Treatments Being Tested

DRUG

HRS-9813 capsules

HRS-9813 capsule; High dose

DRUG

HRS-9813 capsules

HRS-9813 capsule; Low dose

DRUG

HRS-9813 capsule mimetic

HRS-9813 capsule mimetic

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07192939), the sponsor (Guangdong Hengrui Pharmaceutical Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07192939 clinical trial studying?

To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07192939?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07192939?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07192939. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07192939. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.