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ObesityPhase 3NCT06633783

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

A Phase 3 study testing Semaglutide in people with Obesity, run by Hangzhou Jiuyuan Gene Engineering Co. Ltd., at 14 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity
What is being tested?
Semaglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
14 sitesChina
Study dates
30 Oct 2024to 30 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in this trial and sign the informed consent form.
  • Male or female, aged 18-75 years (inclusive) at the time of signing the informed consent form.
  • Body mass index (BMI) ≥28.0 kg/m2 at screening. （4）At least one self-reported unsuccessful weight loss history.

Who cannot join

  • Blood Glucose-Related:
  • Glycated hemoglobin (HbA1c) level ≥6.5% at screening.
  • History of type 1 or type 2 diabetes.
  • Received hypoglycemic drug treatment within 90 days prior to screening.
  • Received GLP-1 receptor agonist treatment within 180 days prior to screening.
  • Obesity-Related:
Show all 29Show fewer
  • （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 trial period, except for the following: (1) liposuction and/or abdominal lipolysis performed \>1 year prior to screening; (2) gastric banding with the band removed \>1 year prior to screening; (3) intragastric balloon placement with the balloon removed \>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 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
  • General Safety:
  • （12） Thyroid diseases: Including a personal or family history of medullary thyroid carcinoma (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.
  • 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.
  • Alanine aminotransferase (ALT) ≥3×ULN, aspartate aminotransferase (AST) ≥3×ULN, or total bilirubin (TBiL) ≥3×ULN at screening.
  • Serum creatinine level ≥1.5 mg/dL (132μmol/L) in males or ≥1.4 mg/dL (123μmol/L) in females at screening.
  • Untreated or poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).
  • Severe cardiac history, defined as New York Heart Association (NYHA) class III and IV at screening, and/or hospitalization for unstable angina pectoris or transient ischemic attack within 60 days prior to screening, and/or stroke (except lacunar infarction) or myocardial infarction within 180 days prior to screening.
  • Gastrointestinal diseases assessed by the investigator to potentially increase the risk after medication (such as obstructive diseases: pyloric obstruction and intestinal obstruction; or gastrointestinal motility disorders: postoperative gastroparesis, idiopathic gastroparesis; or severe active ulcers, etc.).
  • Known or suspected allergy to any component of semaglutide injection or other GLP-1 receptor agonists.
  • Use of drugs that may cause significant weight gain within 90 days prior to screening or expected during the trial, including systemic glucocorticoid therapy for 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).
  • Obesity caused by other endocrine diseases, including hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing\'s syndrome, insulinoma, acromegaly, pseudohypoparathyroidism, and hypogonadism.
  • Known subjects planned for hospitalization for any surgical treatment during the trial at screening.
  • Participated in other clinical trials and used investigational drugs within 90 days prior to screening.
  • History of drug abuse (including drug addiction) and/or alcohol dependence within 180 days prior to screening.
  • Diagnosed with malignant tumors within 5 years prior to screening (except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery).
  • Pregnant or lactating women, females or males with reproductive plans during the trial period or unwilling to use effective contraceptive methods.
  • Subjects who, in the investigator\'s judgment, have any disease or other conditions that may endanger their safety or affect their compliance with the protocol, making them unsuitable for participation in this study.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

xiaoying Li, Doctor contact

0086-021-64041990

xiaoying_li@hotmail.com

14 sites in 1 country

China14 sites

  • Huai an First People's Hospital

    Huaian, Jiangsu

    Li Mao, Doctor

  • Huizhou Central People's Hospital

    Huizhou, Guangdong

    Shu Li, Doctor

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong

    Xiaolin Dong, Doctor

  • Jincheng Grand Hospital

    Jincheng, Shanxi

    Lili Zhang, Doctor

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu

    Haixia Wen, Doctor

  • Luoyang Third People's Hospital

    Luoyang, Henan

    Junhang Tian, Doctor

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

    Luoyang, Henan

    Liping Li, Doctor

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Yibing Lu, Doctor

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan

    Dexue Liu, Doctor

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Biwen Shi, Doctor

  • Xuancheng People's Hospital

    Xuancheng, Anhui

    Chongbing Huang, Doctor

  • Yichang Central People's Hospital

    Yichang, Hubei

    Chaoyang Zeng, Doctor

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Qingju Li, Doctor

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

    Guoyue Yuan, Doctor

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of Semaglutide Injection and Wegovy® for Weight Loss in Obese Subjects

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

Read the detailed 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.

Conditions
Obesity
Being tested
Semaglutide
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    The dose escalation phase, starting with 0.25mg once weekly and increasing every 4 weeks (0.5mg, 1.0mg, 1.7mg), is expected to last 16 weeks; In the dose maintenance phase, the target dose of 2.4mg was maintained for 28 weeks.Treatment duration 44 weeks.

  • SemaglutideDrug

    The dose escalation phase, starting with 0.25mg once weekly and increasing every 4 weeks (0.5mg, 1.0mg, 1.7mg), is expected to last 16 weeks; In the dose maintenance phase, the target dose of 2.4mg was maintained for 28 weeks.Treatment duration 44 weeks.

Study groups in NCT06633783
Study groupRoleWhat they receive
Semaglutide injectionExperimentalSemaglutide：0.25 mg、0.5 mg、1.0mg、1.7mg、2.4mg
Receives: Drug: Semaglutide
Wegovy®Active comparatorWegovy®：0.25 mg、0.5 mg、1.0mg、1.7mg、2.4mg
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

    Percent

    Measured: From baseline at week 0 to week 44

Secondary outcomes (8)

  1. Change in body weight

    Percent

    Measured: From baseline at week 0 to week 28

  2. Subjects who achieve body weight reduction equal to or above 5%

    Number of subjects

    Measured: From baseline at week 0 to week 44

  3. Subjects who achieve body weight reduction equal to or above 10%

    Number of subjects

    Measured: From baseline at week 0 to week 44

  4. Subjects who achieve body weight reduction equal to or above 15%

    Number of subjects

    Measured: From baseline at week 0 to week 44

  5. Change in body mass index (BMI)

    kg/m^2

    Measured: From baseline at week 0 to week 44

  6. Change in waist circumference

    cm

    Measured: From baseline at week 0 to week 44

  7. Change in systolic blood pressure and diastolic blood pressure

    mmHg

    Measured: From baseline at week 0 to week 44

  8. Change in lipids

    mg/dL

    Measured: From baseline at week 0 to week 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start30 Oct 2024 (estimated)
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06633783
Sponsor's protocol ID
JY29-2-302
Status last verified
Jun 2024
First submitted
7 Oct 2024
Last updated
9 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide in people with Obesity, run by Hangzhou Jiuyuan Gene Engineering Co. Ltd., at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact xiaoying Li, Doctor (0086-021-64041990, xiaoying_li@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: From baseline at week 0 to week 44). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06633783.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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