The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity

NCT06830343 | Recruiting Phase 1

• 1 other identifier: SYH9017-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Overweight or Obesity

Keywords

overweight or obesity

Outcome Measures

Primary Outcomes (2)

• Incidence of AEs following single-dose administration of SYH9017 Description:

  up to 49 days after the dosing

• Incidence of AEs following multiple doses administration of SYH9017AEs of SYH 9017 following multiple doses

  up to 140 days after the last dosing

Secondary Outcomes (24)

• The Cmax of SYH9017 following single-dose

  up to 49 days after the dosing

• The AUC of SYH9017 following single-dose

  up to 49 days after the dosing

• The Tmax of SYH9017 following single-dose

  up to 49 days after the dosing

• The t1/2 of SYH9017 following single-dose

  up to 49 days after the dosing

• The CL/F of SYH9017 following single-dose

  *Time Frame:up to 49 days after the dosing

Study Arms (5)

SYH9017 SAD experimental group

EXPERIMENTAL

Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH9017 on Day 1

Drug: SYH9017

Placebo SAD group

PLACEBO COMPARATOR

Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1

Drug: Placebo

SYH9017 MAD experimental group

EXPERIMENTAL

Subjects in MAD experimental groups will receive subcutaneous injection of SYH9017 every 4weeks

Drug: SYH9017

Placebo MAD group

PLACEBO COMPARATOR

Subjects in MAD placebo groups will receive subcutaneous injection of placebo every 4weeks

Drug: Placebo

Positive Control MAD group

ACTIVE COMPARATOR

Subjects in MAD active comparator groups will receive subcutaneous injection of placebo every weeks

Drug: Wegovy ®

Interventions

SYH9017 DRUG

subcutaneous injection once time in SAD and four times in MAD

SYH9017 MAD experimental group; SYH9017 SAD experimental group

Placebo DRUG

subcutaneous injection once time in SAD and four times in MAD

Placebo MAD group; Placebo SAD group

Wegovy ® DRUG

subcutaneous injection once a week

Positive Control MAD group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 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 ≥28.0 kg/m\^2;
• 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, glycated hemoglobin, coagulation function, infectious disease screening, thyroid function, calcitonin, etc.) show normal results or abnormal results deemed not clinically significant by the investigator;
• 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 trial, and ensure that they will personally participate in any procedures; Participants and their partners agree to use effective non-hormonal contraception methods (such as condoms, inert intrauterine devices, female barrier methods \[cervical cap or diaphragm with spermicide\], vaginal contraceptive rings, etc.) from the time of signing the informed consent form until 6 months after the last dose, or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.); Male participants do not plan to donate sperm from the time of signing the informed consent form until 6 months after the last dose, and female participants do not plan to donate eggs from the time of signing the informed consent form until 6 months after the last dose.

You may not qualify 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 drug;
• 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 ideation or behavior), epilepsy, acute biliary disease, or confirmed acute or chronic pancreatitis; participants judged by the investigator to be unsuitable for participation in this clinical study;
• 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 glucose metabolism, or has experienced ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia;
• 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 \<35.5°C or \>37.2°C, pulse rate \<50 beats per minute or \>100 beats per minute, systolic blood pressure ≥160 mmHg or \<90 mmHg, diastolic blood pressure ≥100 mmHg or \<60 mmHg. A single retest is allowed, and participants with abnormalities in both tests will be excluded; ii. Any of the following laboratory abnormalities: a) Fasting plasma glucose ≥7.0 mmol/L or fasting plasma glucose \<3.9 mmol/L or HbA1c level \>6.5%; b) AST or ALT \>2 times the upper limit of normal (ULN), total bilirubin \>1.5 times ULN, deemed clinically significant by the investigator; c) Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73m²; d) Serum amylase or lipase \>3 times ULN; e) Blood low-density lipoprotein cholesterol (LDL-C) ≥4.40 mmol/L; f) Triglycerides (TG) ≥5.65 mmol/L.
• 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, naltrexone-bupropion, systemic steroid medications (administered intravenously, orally, or intra-articularly), antidepressants (selective serotonin reuptake inhibitors (SSRIs), noradrenaline reuptake inhibitors (SNRIs), tricyclics, tetracyclics, etc.), psychotropic medications or sedative drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproate, valproate derivatives, lithium salts), etc.; or use of traditional Chinese medicines, health supplements, meal replacements, or antibiotic drugs or probiotic preparations that influence gut microbiota and thereby affect body weight; or having undergone bariatric surgery within 6 months prior to screening;
• 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 peptidase-4 (DPP-4) inhibitors or glucose-dependent insulinotropic polypeptide (GIP) receptor agonists within 6 months prior to signing the informed consent form.
• 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 consent form;
• 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 prior to screening or within 72 hours before using the investigational drug. Examples include: coffee (more than 1100 mL per day), tea (more than 2200 mL per day), cola (more than 2200 mL per day), energy drinks (more than 1100 mL per day), chocolate (more than 510 g per day);
• 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 collision sports) during the trial period;
• 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 products within 48 hours before using the investigational drug; positive baseline alcohol test (\>0 mg/100 mL) or inability to abstain from alcohol during the trial period;
• 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 trial period;

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Dongyang Liu, PhD

CONTACT

+86-010-82266456; liudongyang@vip.sina.com

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (1)