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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03593668
Other study ID # MET2018
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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