Actively Recruiting
a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）
Led by Tasly Biopharmaceuticals Co., Ltd. · Updated on 2025-08-19
32
Participants Needed
5
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese patients aged between 18 and 75 years
- Diagnosed with NAFLD and MRI-PDFF 6510% within one month prior to screening
- Presence of at least one metabolic risk factor: BMI 6524.0 kg/m2 or abdominal obesity; elevated fasting or 2-h blood glucose, HbA1c 655.7%, history of type 2 diabetes, or HOMA-IR 652.5; resting blood pressure 65130/85 mmHg or use of antihypertensive medication; fasting serum triglycerides 651.70 mmol/L, low HDL cholesterol, or use of lipid-lowering medication
- Stable weight within 6 weeks before enrollment (weight change 645%)
- No plans for fertility within 3 months after consent and willing to use contraception
- Able and willing to provide informed consent and comply with trial procedures
You will not qualify if you...
- Liver cirrhosis or biopsy indicating NASH-F4 stage, or signs of cirrhosis/splenomegaly on clinical or imaging exams
- History or plans for liver transplantation
- Other liver diseases besides NAFLD or suspicion of such diseases
- Diabetes types other than type 2 or use/plans to use insulin, thiazolidinediones, or GLP-1 analog drugs
- Severe or uncontrolled diseases beyond type 2 diabetes, hypertension, or dyslipidemia that increase risk
- Previous or planned weight-loss surgery or significant changes in exercise/diet
- Recent bone injury, fracture, or bone surgery within 2 months
- History of long QT syndrome or prolonged QTcF interval
- Allergy to B1344 or similar biological products
- Use of hepatotoxic drugs or treatments affecting NAFLD within 12 months
- Unstable or non-protocol compliant concomitant treatments
- Previous use of FGF-21 analogs or FGFR1 agonists
- Abnormal lab or clinical screening results including liver enzymes, kidney function, blood counts, glucose, coagulation, blood pressure, heart rate, lipids, or infections
- History of excessive alcohol or caffeine consumption recently
- Recent blood donation or transfusion, or plans to donate during trial
- Needle or blood phobia or inability to tolerate venipuncture
- Drug abuse history or positive drug screening
- Smoking more than 5 cigarettes daily recently or inability to quit during trial
- Pregnancy, breastfeeding, or plans for either during trial
- Skin or abdominal issues affecting injection or extensive tattoos/scars
- Participation in other clinical trials or MRI contraindications
- Other investigator-determined unsuitability for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Sinopharm Tongmei General Hospital
Datong, Shanxi, China
Not Yet Recruiting
4
The First Affiliated Hospital to Nankai University
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
5
The First Affiliated Hospital to Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
Research Team
L
Lai Wei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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