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

NCT03593668 | Unknown Phase 4 DMC

• 1 other identifier: MET2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Drug

Keywords

Metformin; Benaglutide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in body mass index (BMI) of subjects

  Change from Baseline after 12 weeks treatment

• Changes in Body Fat Levels

  Change from Baseline after 12 weeks treatment

• Changes in blood lipid levels

  Change from Baseline after 12 weeks treatment

Study Arms (2)

Metformin

ACTIVE COMPARATOR

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

Drug: Metformin

Benaglutide

ACTIVE COMPARATOR

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

Drug: Benaglutide

Interventions

Metformin DRUG

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.

Also known as: Glucophage, Metformin Hydrochloride Tablet

Metformin

Benaglutide DRUG

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

Also known as: Benaglutide Injection

Benaglutide

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dalong Zhu, MD,PhD

  the Affiliated Drum Tower Hospital of Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalong Zhu, MD,PhD

CONTACT

86-25-83-105302; zhudldr@gmail.com

Yan Bi, MD,PhD

CONTACT

86-25-83-105302; biyan@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: December 30, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

CN (1)