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

Obesity; Drug Clinical Trial

Official title:

Effect 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03593668
• Other study ID #: MET2018
• Status: Recruiting
• Phase: Phase 4
• Start date: December 30, 2017
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Dalong Zhu, MD,PhD
• Phone: 86-25-83-105302
• Email: zhudldr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Screening will be made to select eligible participants before intervention. Patients were randomly assigned to one of two groups(metformin or benaglutide) for therapies for 12 weeks including a two-week dose adjustment period and a 10-week dose stabilization period. Lifestyle interventions will be maintained during the treatment period. Subjects are followed up every 4 weeks for examinations.At the end of the study, data will be collected and analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity; Drug

Intervention

Drug:
• Metformin
2-week dose adjustment period(0-2weeks)[before meals] 0-2d: - ;250mg,po; -. 3-4d: - ;250mg,po; 250mg,po. 5-6d: 250mg,po; 250mg,po; 250mg,po. 7-9d: 250mg,po; 500mg,po; 250mg,po. 10-11d: 250mg,po; 500mg,po; 500mg,po. 12-14d: 500mg,po; 500mg,po; 500mg,po. 10-week dose stabilization period(3-12weeks) Metformin Hydrochloride Tablet 500mg tid po.
• Benaglutide
2-week dose adjustment period(0-2weeks) [before meals] 0-2d: -; 0.1mg,iH; -; 3-4d: -; 0.1mg,iH; 0.1mg,iH; 5-6d: 0.1mg,iH; 0.1mg,iH; 0.1mg,iH; 7-9d: 0.1mg,iH; 0.2mg,iH; 0.1mg,iH; 10-11d: 0.1mg,iH; 0.2mg,iH; 0.2mg,iH; 12-14d: 0.2mg,iH; 0.2mg,iH; 0.2mg,iH. 10-week dose stabilization period(3-12weeks) Benaglutide Injection 0.2mg,100ul,tid,iH

Locations

Country	Name	City	State
China	at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight	Changes in body weight from baseline were observed in patients with simple obesity after 12 weeks of treatment intervention.	Change from Baseline after 12 weeks treatment
Secondary	Changes in body mass index (BMI) of subjects	All 30 subjects of each group would be evaluted by changes in body mass index (BMI) after 12 weeks treatment	Change from Baseline after 12 weeks treatment
Secondary	Changes in Body Fat Levels	Changes in Body Fat Levels from Baseline: Body Composition Analysis	Change from Baseline after 12 weeks treatment
Secondary	Changes in blood lipid levels	The changes in blood lipid levels such as cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein will be measured at the beginning and the end.	Change from Baseline after 12 weeks treatment