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

NCT07128797 | Recruiting Phase 1

• 1 other identifier: TASLY-BM-B1344-NASH-Ib
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

NAFLD (Non-alcoholic Fatty Liver Disease); NASH (Nonalcoholic Steatohepatitis)

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of Adverse Events (AEs) and Serious Adverse Events

  113 days

Secondary Outcomes (13)

• The maximum observed serum concentration (Cmax) of B1344.

  113 days

• Time to peak serum concentration (Tmax) of B1344

  113

• Area under the serum concentration versus time curve from time zero to the last measurable concentration (AUClast) of B1344

  113

• Terminal elimination half-life (t1/2) of B1344

  113

• Compare the changes in triglycerides (TG) after administration compared to the baseline, as well as the percentage changes.

  90 days

Study Arms (5)

B1344 30mg weekly (QW)

EXPERIMENTAL

Drug: B1344

B1344 45mg weekly (QW)

EXPERIMENTAL

Drug: B1344

B1344 60mg Every 2 Weeks (Q2W)

EXPERIMENTAL

Drug: B1344

B1344 90mg Every 2 Weeks (Q2W)

EXPERIMENTAL

Drug: B1344

Placebo QW or Q2W

PLACEBO COMPARATOR

Other: Placebo

Interventions

B1344 DRUG

Subcutaneous injection

B1344 30mg weekly (QW); B1344 45mg weekly (QW); B1344 60mg Every 2 Weeks (Q2W); B1344 90mg Every 2 Weeks (Q2W)

Placebo OTHER

Subcutaneous injection

Placebo QW or Q2W

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese patients aged between 18 and 75 years;
• 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;
• 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.
• Weight stability reported by participants within 6 weeks before enrollment (absolute weight change ≤5%).
• Participants have no fertility plans within 3 months after signing the informed consent and voluntarily take effective contraceptive measures.
• Voluntary participation in the clinical trial, able to sign the informed consent, and capable of understanding and complying with the trial procedures.

You may not qualify if:

• 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.
• History of tumors or liver transplantation, or patients planning to undergo liver transplantation.
• 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.
• 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.
• 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.
• Previous history of weight-loss surgery or plans for weight-loss during the trial, or significant changes in exercise or dietary habits.
• History of extra-bone injury, fracture, or bone-related surgery within 2 months before screening.
• 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.
• Allergic to B1344 or its excipients, or history of allergy to other biological products or severe allergic reactions.
• 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.
• 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.
• Previous use of FGF-21 analogs or FGFR1 agonists.
• 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;

Sponsors & Collaborators

• Tasly Biopharmaceuticals Co., Ltd.: lead

Study Sites (5)

Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University

Beijing, Beijing Municipality, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Sinopharm Tongmei General Hospital

Datong, Shanxi, China

NOT YET RECRUITING

The First Affiliated Hospital to Nankai University

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital to Wenzhou Medical University

Wenzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Lai Wei

CONTACT

13601281862; weilai@mail.tsinghua.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 19, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-07

Locations

CN (5)