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

Primary Purpose

Obesity; Drug

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Metformin

Benaglutide

About this trial

This is an interventional treatment trial for Obesity; Drug focused on measuring Metformin, Benaglutide

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Accurately diagnosed as having type 1 or type 2 diabetes according to the WHO 1999 diagnostic criteria;
Use weight loss drugs within 3 months before screening;
Metformin was used within the first 3 months of screening;
Malignant tumors (excluding basal cell or squamous cell carcinoma treated) within 5 years before enrollment
Alanine aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal or total serum bilirubin (TB) >34.2 μmol/L (>2 mg/dL)
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);
Severe heart, lung, nervous, mental and infectious diseases;
Pregnancy, lactation and recent pregnancy plans;
Alternate or chronic systemic corticosteroid therapy, defined as treatment with any dose of systemic corticosteroids within 3 months of enrollment visit V1 > 4 weeks
History of alcohol abuse, history of abuse of active drugs (opioids, analgesics, etc.) within 6 months before enrollment;
Give any other test drug within 30 days before enrollment or within 5 half-lives of other test drugs;
Patients with past history or family history of medullitary thyroid cancer (MTC) and patients with type 2 multiple endocrine tumor syndrome (MEN2);
Inability to tolerate benalutide, metformin;
Any influence of the investigator's judgment on enrollment.

Sites / Locations

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Metformin

Benaglutide

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in body weight

Changes in body weight from baseline were observed in patients with simple obesity after 12 weeks of treatment intervention.

Secondary Outcome Measures

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

Changes in Body Fat Levels

Changes in Body Fat Levels from Baseline: Body Composition Analysis

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.

Full Information

NCT ID

NCT03593668

First Posted

July 10, 2018

Last Updated

May 23, 2019

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1. Study Identification

Unique Protocol Identification Number

NCT03593668

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 30, 2017 (Actual)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity; Drug

Keywords

Metformin, Benaglutide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Benaglutide

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage, Metformin Hydrochloride Tablet

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Benaglutide

Other Intervention Name(s)

Benaglutide Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in body weight

Description

Changes in body weight from baseline were observed in patients with simple obesity after 12 weeks of treatment intervention.

Time Frame

Change from Baseline after 12 weeks treatment

Secondary Outcome Measure Information:

Title

Changes in body mass index (BMI) of subjects

Description

All 30 subjects of each group would be evaluted by changes in body mass index (BMI) after 12 weeks treatment

Time Frame

Change from Baseline after 12 weeks treatment

Title

Changes in Body Fat Levels

Description

Changes in Body Fat Levels from Baseline: Body Composition Analysis

Time Frame

Change from Baseline after 12 weeks treatment

Title

Changes in blood lipid levels

Description

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.

Time Frame

Change from Baseline after 12 weeks treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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: Accurately diagnosed as having type 1 or type 2 diabetes according to the WHO 1999 diagnostic criteria; Use weight loss drugs within 3 months before screening; Metformin was used within the first 3 months of screening; Malignant tumors (excluding basal cell or squamous cell carcinoma treated) within 5 years before enrollment Alanine aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal or total serum bilirubin (TB) >34.2 μmol/L (>2 mg/dL) 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); Severe heart, lung, nervous, mental and infectious diseases; Pregnancy, lactation and recent pregnancy plans; Alternate or chronic systemic corticosteroid therapy, defined as treatment with any dose of systemic corticosteroids within 3 months of enrollment visit V1 > 4 weeks History of alcohol abuse, history of abuse of active drugs (opioids, analgesics, etc.) within 6 months before enrollment; Give any other test drug within 30 days before enrollment or within 5 half-lives of other test drugs; Patients with past history or family history of medullitary thyroid cancer (MTC) and patients with type 2 multiple endocrine tumor syndrome (MEN2); Inability to tolerate benalutide, metformin; Any influence of the investigator's judgment on enrollment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dalong Zhu, MD,PhD

Phone

86-25-83-105302

zhudldr@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Bi, MD,PhD

Phone

86-25-83-105302

biyan@nju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dalong Zhu, MD,PhD

Organizational Affiliation

the Affiliated Drum Tower Hospital of Nanjing University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dalong Zhu, MD,PhD

Phone

86-25-83-105302

zhudldr@gmail.com

First Name & Middle Initial & Last Name & Degree

Yan Bi, MD,PhD

Phone

86-25-83-105302

biyan@nju.edu.cn

First Name & Middle Initial & Last Name & Degree

Dalong Zhu, MD,PhD

First Name & Middle Initial & Last Name & Degree

Yan Bi, MD，PhD

12. IPD Sharing Statement

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

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