a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Subcutaneous Injections of B1344 Injection in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD） (NCT07128797) is a Phase 1 interventional studying NAFLD (Non-alcoholic Fatty Liver Disease) and NASH (Nonalcoholic Steatohepatitis), sponsored by Tasly Biopharmaceuticals Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This is a randomized, double-blind, multicenter, placebo-controlled, multiple-dose escalating clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of B1344 in patients with NAFLD. Additionally, the trial will conduct preliminary observations on the efficacy of B1344, aiming to provide early proof of concept for B1344 as a therapeutic agent for NASH.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For NAFLD (Non-alcoholic Fatty Liver Disease), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

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.

With a target enrollment of 32 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Chinese patients aged between 18 and 75 years; 2. Patients diagnosed with NAFLD and with a magnetic resonance proton density fat fraction (MRI-PDFF) ≥10% in the screening/baseline period or within one month prior; 3. Presence of any one of the following metabolic risk factors: - Body Mass Index (BMI) ≥24.0 kg/m² or abdominal obesity (male waist circumference ≥90 cm, female waist circumference ≥85 cm); - Fasting blood glucose ≥6.1 mmol/L, or 2-h blood glucose after glucose load ≥7.8 mmol/L, or glycated hemoglobin (HbA1c) ≥5.7%, or history of type 2 diabetes, or Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) ≥2.5; - Resting blood pressure ≥130/85 mmHg, or currently receiving antihypertensive medication; - Fasting serum triglycerides (TG) ≥1.70 mmol/L, high-density lipoprotein cholesterol (HDL-c) ≤1.0 mmol/L (male) and 1.3 mmol/L (female), or currently receiving lipid-lowering medication. 4. Weight stability reported by participants within 6 weeks before enrollment (absolute weight change ≤5%). 5. Participants have no fertility plans within 3 months after signing the willing to sign a consent form and voluntarily take effective contraceptive measures. 6. Voluntary participation in the clinical trial, able to sign the willing to sign a consent form, and capable of understanding and complying with the trial procedures. Who Should NOT Join This Trial: ...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. Chinese patients aged between 18 and 75 years; 2. Patients diagnosed with NAFLD and with a magnetic resonance proton density fat fraction (MRI-PDFF) ≥10% in the screening/baseline period or within one month prior; 3. Presence of any one of the following metabolic risk factors: * Body Mass Index (BMI) ≥24.0 kg/m² or abdominal obesity (male waist circumference ≥90 cm, female waist circumference ≥85 cm); * Fasting blood glucose ≥6.1 mmol/L, or 2-h blood glucose after glucose load ≥7.8 mmol/L, or glycated hemoglobin (HbA1c) ≥5.7%, or history of type 2 diabetes, or Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) ≥2.5; * Resting blood pressure ≥130/85 mmHg, or currently receiving antihypertensive medication; * Fasting serum triglycerides (TG) ≥1.70 mmol/L, high-density lipoprotein cholesterol (HDL-c) ≤1.0 mmol/L (male) and 1.3 mmol/L (female), or currently receiving lipid-lowering medication. 4. Weight stability reported by participants within 6 weeks before enrollment (absolute weight change ≤5%). 5. Participants have no fertility plans within 3 months after signing the informed consent and voluntarily take effective contraceptive measures. 6. Voluntary participation in the clinical trial, able to sign the informed consent, and capable of understanding and complying with the trial procedures. Exclusion Criteria: 1. Liver biopsy, or clinical diagnosis of cirrhosis based on clinical presentation, biochemical and imaging results, or any of the following criteria: ① FIB-4 score ≥3.48 in the screening/baseline period or within 1 month prior, or liver stiffness value (LSM) ≥15 kPa based on FibroScan; ② liver biopsy results indicating NASH-F4 stage within the previous 24 months; ③ clinical examination signs of liver cirrhosis or splenomegaly during the screening/baseline period; ④ abdominal imaging results showing liver nodules or splenomegaly during the screening/baseline period or within 1 month prior. 2. History of tumors or liver transplantation, or patients planning to undergo liver transplantation. 3. History of liver diseases other than NAFLD or clinical suspicion of liver diseases other than NAFLD, including but not limited to secondary NAFLD, hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, alcoholic liver disease, primary sclerosing cholangitis, primary biliary cholangitis, or Wilson's disease. 4. History of other diabetes besides T2DM (such as type 1 diabetes, secondary diabetes, etc.), or currently using or planning to use insulin, thiazolidinediones, and glucagon-like peptide-1 (GLP-1) analog drugs for treatment. 5. Presence of other severe, progressive, or uncontrolled diseases besides T2DM, hypertension, and dyslipidemia, including but not limited to immune system, endocrine system, hematologic system, urinary system, hepatobiliary system, respiratory system, nervous system, psychiatric system, cardiovascular system, digestive system, where participation in this trial would increase participant risk as determined by the investigator. 6. Previous history of weight-loss surgery or plans for weight-loss during the trial, or significant changes in exercise or dietary habits. 7. History of extra-bone injury, fracture, or bone-related surgery within 2 months before screening. 8. Participants with a history of long QT syndrome or family history of sudden death, or males with QTcF \> 450 ms, females with QTcF \> 470 ms. 9. Allergic to B1344 or its excipients, or history of allergy to other biological products or severe allergic reactions. 10. History of drug use related to secondary NAFLD lasting more than 2 weeks within 12 months before screening, including amiodarone, methotrexate, systemic corticosteroids, 5-fluorouracil, irinotecan, tetracycline, tamoxifen, doses exceeding hormone replacement estrogen, anabolic steroids, valproic acid, and other known hepatotoxic drugs. 11. History of concomitant treatment that does not meet protocol requirements before enrollment, or concomitant treatment that meets protocol requirements but cannot maintain a stable dose until the end of the trial, or plans to initiate new concomitant treatments after the first dose until the end of the trial. 12. Previous use of FGF-21 analogs or FGFR1 agonists. 13. Screening/baseline examination results meeting the following criteria: * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 times the upper limit of normal (ULN), total bilirubin \>ULN; * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m²; * Hemoglobin \<120 g/L (male) or \<110 g/L (female); * HbA1c ≥9%; fasting blood glucose ≥13.9 mmol/L; * International normalized ratio (INR) \>1.3; * Platelet count \<110×10⁹/L; * Dual-energy X-ray absorptiometry (DXA) T-score ≤-2.5; * Resting systolic blood pressure \<90 or ≥160 mmHg, resting diastolic blood pressure \<50 or ≥100 mmHg; * Resting heart rate \<60 or \>100 beats/minute; * TG ≥5.65 mmol/L; * Hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody (HCVAb) positive, human immunodeficiency virus (HIV) antibody positive, or positive for serum Treponema pallidum specific antibody (TP-Ab). 14. History of long-term excessive alcohol consumption, or alcohol consumption ≥14 World Health Organization (WHO) alcohol units per week (1 WHO alcohol unit = 10 g pure alcohol) within 3 months before screening, or positive alcohol screening, or unable to refrain from alcohol 48 hours before the first dose until the end of the trial. 15. Excessive consumption of tea, coffee, or caffeinated beverages (daily consumption of more than 8 cups of respective drinks, with 1 cup being 250 mL) within 3 months before screening, or consumption of any caffeinated food or drink (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours before the first dose. 16. History of blood donation, loss of blood ≥200 mL, blood transfusion, or use of blood products within 3 months before screening, or plans to donate blood during the trial. 17. History of needle phobia, blood phobia, or frequent episodes of orthostatic hypotension, or inability to tolerate venipuncture. 18. History of drug abuse, or positive urine drug abuse screening. 19. Smoking more than 5 cigarettes daily within the last 3 months or cannot completely quit smoking during the trial. 20. Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the trial. 21. Any skin or abdominal wall anomalies that would affect subcutaneous injection, or tattoos or scars covering more than 50% of the abdominal wall surface area. 22. Participation in other clinical trials and receiving trial interventions within the last 3 months. 23. Existing MRI examination contraindications or inability to cooperate with MRI examinations before screening. 24. Other circumstances deemed unsuitable for participation in this trial by the investigator.

Treatments Being Tested

DRUG

B1344

Subcutaneous injection

OTHER

Placebo

Subcutaneous injection

Locations (5)

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.

Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University

Beijing, Beijing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Sinopharm Tongmei General Hospital

Datong, Shanxi, China

The First Affiliated Hospital to Nankai University

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital to Wenzhou Medical University

Wenzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07128797), the sponsor (Tasly Biopharmaceuticals 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 NCT07128797 clinical trial studying?

Who can participate in NCT07128797?

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 NCT07128797?

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 NCT07128797. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07128797. 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.