Benaglutide or Metformin for Simple Obesity Weight Control: Effect and Safety
This study aims to evaluate and compare the effectiveness and safety of Benaglutide and Metformin in helping individuals with simple obesity lose weight over a 12-week period.
Metformin
+ Benaglutide
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: December 30, 2017
Actual date on which the first participant was enrolled.This clinical trial focuses on understanding the effectiveness and safety of two treatments, Benaglutide and Metformin, in helping people with simple obesity who struggle with weight control. The goal is to find a better way to manage obesity and improve health. The study is open to individuals who meet specific criteria, ensuring they are suitable for the trial. Participants are randomly assigned to one of two groups, either receiving Benaglutide or Metformin. The treatment lasts for 12 weeks, including a two-week dose adjustment period and a 10-week dose stabilization period. Throughout this time, lifestyle interventions are maintained to support the treatment. Participants return every 4 weeks for check-ups. The primary outcome of interest is the change in body weight after the 12-week treatment period. Data collected will be thoroughly analyzed to evaluate the effectiveness and safety of both treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: (1)20 years old≤70 years old; (2) simple obesity, gender is not limited; (3) 28.0≤BMI≤37.5kg/m2; (4) Before the screening period, the body weight was controlled by lifestyle interventions (diet and exercise) for at least 3 months, and weight was decreased by \<5% from baseline; (5) Agree to sign the informed consent form; Exclusion Criteria: 1. Accurately diagnosed as having type 1 or type 2 diabetes according to the WHO 1999 diagnostic criteria; 2. Use weight loss drugs within 3 months before screening; 3. Metformin was used within the first 3 months of screening; 4. Malignant tumors (excluding basal cell or squamous cell carcinoma treated) within 5 years before enrollment 5. Alanine aminotransferase or aspartate aminotransferase \> 3 times the upper limit of normal or total serum bilirubin (TB) \>34.2 μmol/L (\>2 mg/dL) 6. Patients with moderate/severe renal impairment or end-stage renal disease (eGFR \< 60 mL/min/1.73 m2); male subjects with serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL Serum Cr in female subjects was ≥124 μmol/L (\>1.40 mg/dL); 7. Severe heart, lung, nervous, mental and infectious diseases; 8. Pregnancy, lactation and recent pregnancy plans; 9. Alternate or chronic systemic corticosteroid therapy, defined as treatment with any dose of systemic corticosteroids within 3 months of enrollment visit V1 \> 4 weeks 10. History of alcohol abuse, history of abuse of active drugs (opioids, analgesics, etc.) within 6 months before enrollment; 11. Give any other test drug within 30 days before enrollment or within 5 half-lives of other test drugs; 12. Patients with past history or family history of medullitary thyroid cancer (MTC) and patients with type 2 multiple endocrine tumor syndrome (MEN2); 13. Inability to tolerate benalutide, metformin; 14. Any influence of the investigator's judgment on enrollment.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, ChinaOpen at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University in Google Maps