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

• ClinicalTrials.gov Identifier: NCT03593668
• Recruitment Status: Unknown
• First Posted: July 20, 2018
• Last Update Posted: May 24, 2019
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Information provided by (Responsible Party): Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity; Drug	Drug: Metformin; Drug: Benaglutide	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 30, 2017
• Estimated Primary Completion Date: October 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Metformin; Metformin Hydrochloride Tablet 500mg po by month,three times a day for 12 weeks	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.; Other Names: Glucophage; Metformin Hydrochloride Tablet
Active Comparator: Benaglutide; Benaglutide Injection 0.2mg, iH,po, three times a day for 3 12 weeks	Drug: 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; Other Name: Benaglutide Injection

Outcome Measures

Primary Outcome Measures :

1. Changes in body weight [ Time Frame: Change from Baseline after 12 weeks treatment ]
   Changes in body weight from baseline were observed in patients with simple obesity after 12 weeks of treatment intervention.

Secondary Outcome Measures :

1. Changes in body mass index (BMI) of subjects [ Time Frame: Change from Baseline after 12 weeks treatment ]
   All 30 subjects of each group would be evaluted by changes in body mass index (BMI) after 12 weeks treatment
2. Changes in Body Fat Levels [ Time Frame: Change from Baseline after 12 weeks treatment ]
   Changes in Body Fat Levels from Baseline: Body Composition Analysis
3. Changes in blood lipid levels [ Time Frame: Change from Baseline after 12 weeks treatment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Dalong Zhu, MD,PhD; 86-25-83-105302; zhudldr@gmail.com

Contact: Yan Bi, MD,PhD; 86-25-83-105302; biyan@nju.edu.cn

Locations

China, Jiangsu

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University; Recruiting

Nanjing, Jiangsu, China, 210008

Contact: Dalong Zhu, MD,PhD 86-25-83-105302 zhudldr@gmail.com

Contact: Yan Bi, MD,PhD 86-25-83-105302 biyan@nju.edu.cn

Principal Investigator: Dalong Zhu, MD,PhD

Sub-Investigator: Yan Bi, MD，PhD

Sponsors and Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

• Principal Investigator: Dalong Zhu, MD,PhD; the Affiliated Drum Tower Hospital of Nanjing University

More Information

• Responsible Party: Dalong Zhu, Chief Physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT03593668
• Other Study ID Numbers: MET2018
• First Posted: July 20, 2018
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Metformin; Benaglutide

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs