A Phase III Study Comparing the Weight Loss Effects of Semaglutide Injection and Wegovy®

Last updated: October 7, 2024
Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Weight Loss

Diabetes Prevention

Treatment

Semaglutide

Clinical Study ID

NCT06633783
JY29-2-302
  • Ages 18-75
  • All Genders

Study Summary

The purpose of the study is to compare the effect on body weight in subjects taking semaglutide injection or subjects taking Wegovy®.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntarily participate in this trial and sign the informed consent form.

  2. Male or female, aged 18-75 years (inclusive) at the time of signing the informedconsent form.

  3. Body mass index (BMI) ≥28.0 kg/m2 at screening. (4)At least one self-reportedunsuccessful weight loss history.

Exclusion

Exclusion Criteria:

  • Blood Glucose-Related:
  1. Glycated hemoglobin (HbA1c) level ≥6.5% at screening.

  2. History of type 1 or type 2 diabetes.

  3. Received hypoglycemic drug treatment within 90 days prior to screening.

  4. Received GLP-1 receptor agonist treatment within 180 days prior to screening.

  • Obesity-Related:

(5)Self-reported weight change >5 kg within 90 days prior to screening,regardless of medical history.

(6)Received any drug treatment for obesity within 90 days prior to screening. (7)Previous or planned surgical or device treatment for obesity during the trialperiod, except for the following: (1) liposuction and/or abdominal lipolysisperformed >1 year prior to screening; (2) gastric banding with the band removed >1 year prior to screening; (3) intragastric balloon placement with the balloonremoved >1 year prior to screening.

  • Psychological Health-Related:

(8)History of severe depression or a Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.

(9)Diagnosed with other severe mental illnesses, including schizophrenia,schizoaffective disorder, paranoid psychosis, bipolar (affective) disorder,epilepsy-induced mental disorder, and mental retardation with mental disorders.

(10)History of suicidal behavior. (11)Suicidal ideation corresponding to type 4 or 5on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.

  • General Safety:

(12) Thyroid diseases: Including a personal or family history of medullary thyroidcarcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); or calcitonin (CT) ≥50ng/L at screening; or thyroid-stimulating hormone (TSH) >6.0mIU/L or <0.4mIU/L at screening; or concurrent hyperthyroidism.

(13) History of acute or chronic pancreatitis, or blood amylase ≥3×ULN at screening,or triglycerides (TG) ≥5.65 mmol/L (500 mg/dL) at screening.

(14) Alanine aminotransferase (ALT) ≥3×ULN, aspartate aminotransferase (AST) ≥3×ULN,or total bilirubin (TBiL) ≥3×ULN at screening.

(15) Serum creatinine level ≥1.5 mg/dL (132μmol/L) in males or ≥1.4 mg/dL (123μmol/L) in females at screening.

(16) Untreated or poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).

(17) Severe cardiac history, defined as New York Heart Association (NYHA) class IIIand IV at screening, and/or hospitalization for unstable angina pectoris ortransient ischemic attack within 60 days prior to screening, and/or stroke (exceptlacunar infarction) or myocardial infarction within 180 days prior to screening.

(18) Gastrointestinal diseases assessed by the investigator to potentially increasethe risk after medication (such as obstructive diseases: pyloric obstruction andintestinal obstruction; or gastrointestinal motility disorders: postoperativegastroparesis, idiopathic gastroparesis; or severe active ulcers, etc.).

(19) Known or suspected allergy to any component of semaglutide injection or otherGLP-1 receptor agonists.

(20) Use of drugs that may cause significant weight gain within 90 days prior toscreening or expected during the trial, including systemic glucocorticoid therapyfor more than 1 week; tricyclic antidepressants (such as amitriptyline, imipramine,clomipramine, doxepin); antipsychotic or antiepileptic drugs (such as mirtazapine,paroxetine, phenelzine, chlorpromazine hydrochloride, chlorpromazine, olanzapine,valproic acid and its derivatives, lithium preparations, methimazole).

(21) Obesity caused by other endocrine diseases, including hypothalamic obesity,pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma,acromegaly, pseudohypoparathyroidism, and hypogonadism.

(22) Known subjects planned for hospitalization for any surgical treatment duringthe trial at screening.

(23) Participated in other clinical trials and used investigational drugs within 90days prior to screening.

(24) History of drug abuse (including drug addiction) and/or alcohol dependencewithin 180 days prior to screening.

(25) Diagnosed with malignant tumors within 5 years prior to screening (except foradequately treated cervical carcinoma in situ, basal cell or squamous cell skincancer, local prostate cancer after radical surgery, and breast ductal carcinoma insitu after radical surgery).

(26) Pregnant or lactating women, females or males with reproductive plans duringthe trial period or unwilling to use effective contraceptive methods.

(27) Subjects who, in the investigator's judgment, have any disease or otherconditions that may endanger their safety or affect their compliance with theprotocol, making them unsuitable for participation in this study.

Study Design

Total Participants: 370
Treatment Group(s): 1
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
October 30, 2024
Estimated Completion Date:
October 30, 2026

Study Description

The study will involve participants engaging in discussions with study staff regarding healthy dietary choices, strategies for increasing physical activity, and additional methods for achieving weight loss, alongside the administration of the study medication. Participants will be randomly assigned to receive either semaglutide injection or Wegovy®. The study medication will be administered via a weekly subcutaneous injection using a fine needle in the abdominal skinfold. The duration of the study will be approximately 2 years, during which participants will attend 13 clinic visits with the study physician.

Connect with a study center

  • Xuancheng People's Hospital

    Xuancheng, Anhui
    China

    Site Not Available

  • Huizhou Central People's Hospital

    Huizhou, Guangdong
    China

    Site Not Available

  • Luoyang Third People's Hospital

    Luoyang, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Yichang Central People's Hospital

    Yichang, Hubei
    China

    Site Not Available

  • Huai an First People's Hospital

    Huaian, Jiangsu
    China

    Site Not Available

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu
    China

    Site Not Available

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong
    China

    Site Not Available

  • Jincheng Grand Hospital

    Jincheng, Shanxi
    China

    Site Not Available

  • Jincheng Grand Hospital

    Jincheng, Shanxi
    China

    Site Not Available

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