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UnknownPhase 4

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

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

Asset

Beinaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≤37.5

Primary endpoint

Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03593668
Org study IDMET2018

Timeline

Milestones

Study start2017-12-30actual
Study first posted2018-07-20actual
Last update posted2019-05-24actual
Primary completion2019-10estimated (month precision)
Study completion2019-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age20 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
3
Cardiometabolic biomarkers
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Changes in body weight

Time frame:Change from Baseline after 12 weeks treatment

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Changes in body mass index (BMI) of subjects

Time frame:Change from Baseline after 12 weeks treatment

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in Body Fat Levels

Time frame:Change from Baseline after 12 weeks treatment

Total fat mass

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Changes in blood lipid levels

Time frame:Change from Baseline after 12 weeks treatment

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.