Effect and Safety of Benaglutide or Metformin in Patients With Simple Obesity Who Have Inadequate Weight Control

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Treatments: Metformin

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.