Clinical trial NCT03593668: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity; Drug
Keywords: Metformin
Benaglutide
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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:

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.

Primary outcomes:
measure: Changes in body weight
timeFrame: Change from Baseline after 12 weeks treatment
Secondary outcomes:
measure: Changes in body mass index (BMI) of subjects
timeFrame: Change from Baseline after 12 weeks treatment
measure: Changes in Body Fat Levels
timeFrame: Change from Baseline after 12 weeks treatment
measure: Changes in blood lipid levels
timeFrame: Change from Baseline after 12 weeks treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
affiliation: the Affiliated Drum Tower Hospital of Nanjing University
name: Dalong Zhu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: