A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Semaglutide injection, which is being compared to Wegovy® to see how effective it is for weight management in people who are obese. To qualify for the study, participants need to be between 18 and 70 years old, have a body mass index (BMI) of 28 or higher, and have tried unsuccessfully to lose weight in the past. It's important for potential participants to understand that they cannot have a history of certain health conditions, like diabetes or serious mental illnesses, and they must not be pregnant or planning to become pregnant during the study.

Participants in the trial can expect to receive either the Semaglutide injection or Wegovy®, and they will be monitored closely for their weight loss progress over about 44 weeks. The study will help researchers find out how safe and effective Semaglutide is compared to Wegovy®. Anyone considering joining should be aware that they will need to follow a specific treatment plan, and they must be willing to provide informed consent before starting. The trial is not yet recruiting, so interested individuals will need to wait for more information on how to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-70 years old, gender is not limited;
• • Body mass index (BMI) ≥ 28 kg/m2;
• • Self-report at least one unsuccessful diet and weight loss history;
• • Patients must give informed consent to this study before the trial and sign the informed consent voluntarily.
• Exclusion Criteria:
• • Pregnant or lactating women or men or women of childbearing age who had a pregnancy plan during the study period (including a spouse), or who refused to take the contraceptive measures specified in the programme during the study period;
• • Have a history of diabetes of any type;
• • Patients who had used any hypoglycemic drugs within 90 days before screening;
• • Personal or first-degree relatives have a personal or family history of thyroid C-cell tumor or multiple endocrine tumor syndrome type 2;
• • Use of any drugs for weight management within 90 days prior to screening;
• • Previous or planned weight loss related treatment through surgery or other weight loss means during the study period;
• • Have a history of major depression or serious mental illness;
• • Mental Health Scale (PHQ-9) score ≥ 15 during screening;
• • History of acute pancreatitis within 180 days prior to screening;
• • Have a history of chronic pancreatitis or pancreatic surgery;
• * Laboratory tests during screening meet any of the following criteria:
• • 1. Alanine aminotransferase (ALT)\> 2.5× upper limit of normal (ULN), aspartate aminotransferase (AST)\>2.5 ULN;
• • 2. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2;
• • 3. calcitonin ≥ 50 ng/L (pg/mL);
• • 4. Triglyceride (TG) ≥500 mg/dl (5.7mmol/L);
• • 5. Thyroid stimulating hormone (TSH) \>6 mIU/L or \<0.4 mIU/L.
• * When virological tests at the time of screening show any of the following:
• • 1. Hepatitis C virus (HCV) antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value;
• • 2. HBsAg positive and Hepatitis B virus (HBV) DNA test value exceeds the upper limit of normal value;
• • 3. HIV positive;
• • 4. Active syphilis: the screening period of treponema pallidum antibody positive and non-Treponema pallidum serum test (RPR or TRUST) positive;
• • Uncontrolled or poorly treated hypertension;
• • Clinically significant cardiovascular and cerebrovascular disease in the 6 months prior to screening;
• • People who are allergic to Semaglutide injection or any component of Wegovy®, or to other GLP-1 receptor agonists, or who have a pre-existing allergic disorder;
• • Participated in any other clinical trial within 3 months prior to screening;
• • The subject is unable to comply with the treatment plan and diet and exercise plan established by the investigator;
• • There are secondary causes affecting body weight;
• • There is hypothyroidism at the time of screening that is not controlled with stable drug dosages;
• • Have a history of major surgery within 6 months prior to screening;
• • A history of drug abuse or alcohol dependence within the 6 months prior to screening;
• • History of malignant tumor within 5 years before screening;
• • Patients with other diseases that the researchers assessed would affect the safety of the subjects, affect the efficacy evaluation or compliance, or other conditions that the researchers considered unsuitable for enrollment.