Actively Recruiting
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of Multiple Subcutaneous Injections of B1344 in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Led by Tasly Biopharmaceuticals Co., Ltd. · Updated on 2025-08-19
32
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of a drug called B1344 in patients with Nonalcoholic Fatty Liver Disease (NAFLD). This randomized, double-blind, placebo-controlled trial also observes early signs of how B1344 might work as a treatment for Nonalcoholic Steatohepatitis (NASH). The study is conducted across multiple centers and is led by Tasly Biopharmaceuticals Co., Ltd. Participants receive multiple subcutaneous injections of B1344 at varying doses: 30 mg and 45 mg weekly, or 60 mg and 90 mg every two weeks. There is also a placebo group receiving injections on the same schedule. The trial is designed with escalating doses to assess different treatment levels safely. During the study, participants will have regular assessments including laboratory tests, MRI scans to measure liver fat, blood tests for liver enzymes and blood sugar control, and monitoring of any side effects. The main outcome measured is the frequency and severity of adverse events over 113 days. Secondary outcomes include drug concentration in the blood, changes in liver fat, triglycerides, body weight, and other metabolic markers, with total participation lasting about 90 to 113 days.
CONDITIONS
Brief 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 with magnetic resonance proton density fat fraction (MRI-PDFF) of at least 10%
- Presence of at least one metabolic risk factor: BMI 24.0 kg/m² or higher, high waist circumference, elevated fasting blood glucose or HbA1c, type 2 diabetes, high blood pressure, or abnormal lipid levels
- Stable weight within 6 weeks before enrollment (weight change no more than 5%)
- No fertility plans within 3 months after consent and willing to use effective contraception
- Able to understand, voluntarily consent, and comply with trial procedures
You will not qualify if you...
- Clinical or biopsy-proven cirrhosis or advanced liver disease
- History or planned liver transplantation
- Other liver diseases besides NAFLD such as hepatitis B or C, autoimmune hepatitis, alcoholic liver disease, or Wilson's disease
- Diabetes types other than type 2 or use/planned use of insulin, thiazolidinediones, or GLP-1 analogs
- Severe or uncontrolled diseases beyond type 2 diabetes, hypertension, and dyslipidemia
- Recent or planned weight-loss surgery, or significant changes in diet or exercise
- Recent bone injury or surgery within 2 months
- History of long QT syndrome or abnormal QTcF intervals
- Allergies to B1344 or related products
- Use of certain hepatotoxic drugs within the past year
- Use of concomitant treatments not meeting protocol requirements
- Previous use of FGF-21 analogs or FGFR1 agonists
- Abnormal lab values including liver enzymes, kidney function, blood counts, coagulation, or positive infections
- History of excessive alcohol consumption or inability to abstain during the trial
- Excessive caffeine intake or consumption within 48 hours before dosing
- Recent blood donation or transfusion within 3 months
- Needle or blood phobia or inability to tolerate blood draws
- Drug abuse history or positive drug screening
- Smoking more than 5 cigarettes daily or unable to quit during the trial
- Pregnant or breastfeeding women, or planning pregnancy
- Skin or abdominal abnormalities affecting injections
- Participation in another clinical trial within 3 months
- Contraindications to MRI or inability to cooperate with MRI exams
- Other investigator-determined reasons making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 113 days
Participants receive multiple subcutaneous injections of B1344 or placebo to evaluate safety, tolerability, and pharmacokinetics.
Weekly or biweekly visits for injections depending on assigned dose
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
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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