Actively Recruiting
The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity
Led by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Updated on 2026-04-06
66
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity.
CONDITIONS
Official Title
The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese adults aged 18 to 60 years with overweight or obesity
- At least one-third of participants from each gender
- BMI 24.0-28.0 kg/m2 for single ascending dose phase
- Weight ≥70 kg (males) or ≥60 kg (females) and BMI ≥28.0 kg/m2 for multiple ascending dose phase
- Weight change less than 5% in past 3 months
- Normal or clinically acceptable vital signs, physical exam, ECG, chest X-ray, abdominal ultrasound, and lab tests
- Able to understand and sign informed consent and agree to use non-hormonal contraception or have permanent contraception
- Male participants agree not to donate sperm during study and for 6 months after last dose
- Female participants agree not to donate eggs during study and for 6 months after last dose
You will not qualify if you...
- History of severe drug or food allergies or potential allergy to study drug
- Significant diseases affecting pancreas, liver, kidneys, gastrointestinal tract, skin, heart, lungs, blood, nervous system, or other conditions affecting safety or drug metabolism
- History of cancer (except cured basal cell carcinoma or cervical carcinoma in situ), psychiatric disorders, epilepsy, biliary disease, or pancreatitis
- Diagnosed diabetes, thyroid dysfunction, Cushing's syndrome, polycystic ovary syndrome, glucagonoma, pheochromocytoma, or other endocrine diseases affecting glucose metabolism
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Abnormal vital signs or lab test results as specified, including blood pressure, pulse, blood glucose, liver enzymes, kidney function, amylase/lipase, cholesterol, and triglycerides
- Use of drugs or products affecting body weight within 6 months prior to screening
- Use of GLP-1 receptor agonists, DPP-4 inhibitors, or GIP receptor agonists within 6 months prior to consent
- Use of any medication, traditional medicines, supplements, or health products within 4 weeks prior to consent
- High habitual intake of caffeine or xanthine-containing substances within 1 month prior to screening or 72 hours before drug use
- Surgery within 6 months prior to screening or planned during study, or plans for vigorous physical activity during study
- History of drug abuse or positive drug test within 1 year prior to consent
- Blood loss or donation >400 mL within 3 months prior to consent, or blood transfusions
- Alcohol consumption over 14 units per week within 3 months prior to consent or alcohol use within 48 hours before drug use
- Smoking more than 5 cigarettes daily within 6 months prior to consent or smoking within 48 hours before drug use
- Participation in other clinical trials within 3 months prior to consent
- Pregnant or breastfeeding women, or positive pregnancy test at screening
- History of vasovagal syncope, hemophobia, or difficulty with venipuncture
- Difficulty with subcutaneous injection administration
- Any other factors making participation unsuitable as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer, /
CONTACT
D
Dongyang Liu, PhD
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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