UnknownPhase 4

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

China60 participantsStarted 2017-12-30

Plain-language 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.

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in body weight

Timeframe: Change from Baseline after 12 weeks treatment

Trial details

NCT IDNCT03593668

SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10

Contact for this trial

Dalong Zhu, MD,PhD

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

View on ClinicalTrials.gov More Obesity; Drug trials