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

NCT06633783 | Not Yet Recruiting Phase 3

• 1 other identifier: JY29-2-302
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Percent

  From baseline at week 0 to week 44

Secondary Outcomes (8)

• Change in body weight

  From baseline at week 0 to week 28

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

  From baseline at week 0 to week 44

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

  From baseline at week 0 to week 44

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

  From baseline at week 0 to week 44

• Change in body mass index (BMI)

  From baseline at week 0 to week 44

Study Arms (2)

Semaglutide injection

EXPERIMENTAL

Semaglutide：0.25 mg、0.5 mg、1.0mg、1.7mg、2.4mg

Drug: Semaglutide

Wegovy®

ACTIVE COMPARATOR

Wegovy®：0.25 mg、0.5 mg、1.0mg、1.7mg、2.4mg

Drug: Semaglutide

Interventions

Semaglutide DRUG

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.

Semaglutide injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• （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.
• (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.

Sponsors & Collaborators

• Hangzhou Jiuyuan Gene Engineering Co. Ltd.,: lead

Study Sites (14)

Xuancheng People's Hospital

Xuancheng, Anhui, China

Location

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Location

Luoyang Third People's Hospital

Luoyang, Henan, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Location

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Yichang Central People's Hospital

Yichang, Hubei, China

Location

Huai an First People's Hospital

Huaian, Jiangsu, China

Location

The Second People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Location

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Location

Jincheng Grand Hospital

Jincheng, Shanxi, China

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

Central Study Contacts

xiaoying Li, Doctor

CONTACT

0086-021-64041990; xiaoying_li@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)