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Tests treatment safety and results for Overweight or Obesity
Official title The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity
ClinicalTrials.gov ID: NCT06830343
What this study is testing
What is SYH9017?
SYH9017 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight or obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Chinese male or female adult participants aged 18-60 years (inclusive) with overweight or obesity, with no less than one-third of the participants of...
- SAD phase: Body Mass Index (BMI) = weight (kg)/height\^2 , with BMI in the range of 24.0-28.0 kg/m\^2 (inclusive); MAD phase: Weight ≥70 kg (for...
- Weight change \<5% in the 3 months prior to screening (can be based on self-report); calculated as: (weight 12 weeks before screening - weight at...
- Vital signs, physical examination, 12-lead electrocardiogram, chest X-ray (anteroposterior view), abdominal color Doppler ultrasound, clinical...
- Able to read and understand the written informed consent related to the study information, fully aware of the study content, process, and possible...
You likely can't join if
- A history of severe drug or food allergies, or any participant who is judged by the investigator to potentially be allergic to the investigational...
- A history of significant diseases involving the pancreas, liver, kidneys, gastrointestinal tract, skin, cardiovascular system, respiratory system...
- A history of malignancy (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix), psychiatric disorders (such as...
- Diagnosed with diabetes, thyroid dysfunction (abnormal TSH, FT3, or FT4 levels), Cushing's syndrome, polycystic ovary syndrome, a history of...
- A personal or family history of medullary thyroid carcinoma (MTC) or a history of multiple endocrine neoplasia type 2 (MEN2).
- Any one of the following criteria is met: i. Participants with one or more abnormal vital signs: body temperature \ 37.2°C, pulse rate \ 100 beats...
See the full eligibility criteria
Who can join
- Chinese male or female adult participants aged 18-60 years (inclusive) with overweight or obesity, with no less than one-third of the participants of either gender;
- SAD phase: Body Mass Index (BMI) = weight (kg)/height\^2 , with BMI in the range of 24.0-28.0 kg/m\^2 (inclusive); MAD phase: Weight ≥70 kg (for males) or ≥60 kg (for females), and BMI = weight (kg)/height\^2 , with BMI...
- Weight change \<5% in the 3 months prior to screening (can be based on self-report); calculated as: (weight 12 weeks before screening - weight at screening) / weight at screening \ 100%;
- Vital signs, physical examination, 12-lead electrocardiogram, chest X-ray (anteroposterior view), abdominal color Doppler ultrasound, clinical laboratory tests (complete blood count, urinalysis, blood biochemistry...
- Able to read and understand the written informed consent related to the study information, fully aware of the study content, process, and possible adverse reactions, voluntarily sign the informed consent form before the...
What rules you out
- A history of severe drug or food allergies, or any participant who is judged by the investigator to potentially be allergic to the investigational drug;
- A history of significant diseases involving the pancreas, liver, kidneys, gastrointestinal tract, skin, cardiovascular system, respiratory system, hematological system, central nervous system, or other conditions that...
- A history of malignancy (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix), psychiatric disorders (such as depression, schizophrenia, bipolar disorder, or a history of suicidal...
- Diagnosed with diabetes, thyroid dysfunction (abnormal TSH, FT3, or FT4 levels), Cushing's syndrome, polycystic ovary syndrome, a history of glucagonoma or pheochromocytoma, or other endocrine diseases that may affect...
- A personal or family history of medullary thyroid carcinoma (MTC) or a history of multiple endocrine neoplasia type 2 (MEN2).
- Any one of the following criteria is met: i. Participants with one or more abnormal vital signs: body temperature \ 37.2°C, pulse rate \ 100 beats per minute, systolic blood pressure ≥160 mmHg or \ 6.5%; b) AST or ALT...
- During the multiple-dose phase: Use of any approved or unapproved drugs or products that may affect body weight within 6 months prior to screening, including but not limited to orlistat, phentermine-topiramate...
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1 analogs (such as liraglutide, dulaglutide, lixisenatide, exenatide, albiglutide, benraliptide, polyethylene glycol loxenatide, etc.) or any dipeptidyl...
- Use of any prescription medications, over-the-counter medications, traditional Chinese patent medicines, herbal remedies, vitamin dietary supplements, or health products within 4 weeks prior to signing the informed...
- Habitual intake of or consumption of excessive amounts of xanthine or caffeine-containing foods, beverages, or other substances that may affect drug absorption, distribution, metabolism, or excretion within 1 month...
- Undergone surgery (including cosmetic, dental, and oral surgeries) within 6 months prior to screening or planned during the trial period, or plans to engage in vigorous physical activity (including contact sports or...
- A history of drug abuse or a positive drug screening test within 1 year prior to signing the informed consent form;
- Loss of blood or donation of more than 400 mL of blood within 3 months prior to signing the informed consent form, or receipt of blood transfusions or use of blood products;
- Consumption of more than 14 units of alcohol per week (1 unit = 285 mL of beer; 25 mL of spirits; 150 mL of wine) within 3 months prior to signing the informed consent form, or consumption of any alcohol-containing...
- Smoking ≥5 cigarettes daily within 6 months prior to signing the informed consent form, smoking within 48 hours before using the investigational drug, or inability to cease the use of any tobacco products during the...
- Participation in any clinical trial involving investigational drugs or medical devices within 3 months prior to signing the informed consent form;
- Pregnant and/or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening and before dosing;
- A history of vasovagal syncope or hemophobia, or difficulty with venipuncture for any reason, making it intolerable;
- Difficulty with subcutaneous injection administration;
- Any other factors deemed by the investigator to make the participant unsuitable for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.