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Benaglutide or Metformin for Simple Obesity Weight Control: Effect and Safety

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Study Aim

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.

What is being tested

Metformin

+ Benaglutide

Drug
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 20 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: December 2017
See protocol details

Summary

Principal SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ContactDalong Zhu, MD,PhDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEffect and Safety of Benaglutide or Metformin in Patients With Simple Obesity Who Have Inadequate Weight Control :A Randomized, Open, Controlled and Single-site Clinical Trail
Principal SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ContactDalong Zhu, MD,PhDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Metformin Hydrochloride Tablet 500mg po by month,three times a day for 12 weeks

Group II

Active Comparator
Benaglutide Injection 0.2mg, iH,po, three times a day for 3 12 weeks

Study 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

Recruiting

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
SuspendedOne Study Center
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