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ObesityPhase 3NCT03671733

Effects of GLP-1 RAs on Weight and Metabolic Indicators in Obese Patients

A Phase 3 study testing Liraglutide, Exenatide and Exenatide Microspheres for Injection in people with Obesity, run by Xiangya Hospital of Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This studay evaluates the effect of the glucagon-like peptide-1 (GLP-1) receptor agonist,including Liraglutide,Exenatide and Exenatide Microspheres for Injection,in the treatment of subjects who are overweight or obese. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Liraglutide, Exenatide and Exenatide Microspheres for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
1 Sep 2018to 1 Sep 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 to 65 years (to the date of screening)；
  • The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).
  • Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.
  • Weight stable for more than 3 months (weight fluctuations <5%).

Who cannot join

  • pregnant female.
  • Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.
  • Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.
  • Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.
  • Nearly a month had surgery, trauma, infection and so on.
  • Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.
  • Poor medication compliance or serious side effects (severe rash, syncope, etc.).

Trial locations and contacts

1 site in 1 country.

Jing Wu contact

+86-13574120508

wujing0731@163.com

China1 site, 1 recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

    Jing Wu, +86-13574120508, wujing0731@163.com

    Recruiting

Other trials in China

About this study

This studay evaluates the effect of the glucagon-like peptide-1 (GLP-1) receptor agonist,including Liraglutide,Exenatide and Exenatide Microspheres for Injection,in the treatment of subjects who are overweight or obese.

Conditions
Obesity
Being tested
Liraglutide, Exenatide, Exenatide Microspheres for Injection
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Victoza

    The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards, 1.8mg per day, subcutaneous injection.

  • ExenatideDrug

    Also called Byetta

    10mcg once a day for 4 weeks increased to 10mcg twice a day for 8 weeks.

  • Exenatide Microspheres for InjectionDrug

    Also called Bydureon

    Exenatide 2 mg injection once weekly for 12 weeks.

Study groups in NCT03671733
Study groupRoleWhat they receive
LiraglutideExperimentalAdministered subcutaneously (s.c., under the skin) once daily for 12 weeks.
Receives: Drug: Liraglutide
ExenatideExperimentalAdministered subcutaneously (s.c., under the skin) twice daily for 12 weeks.
Receives: Drug: Exenatide
Exenatide Microspheres for InjectionExperimentalAdministered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
Receives: Drug: Exenatide Microspheres for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Change at 3 months

    Measured in kilograms

    Measured: baseline , 3 months

Secondary outcomes (14)

  1. Change in waist circumference

    Measured in cm

    Measured: baseline and 3 months

  2. Change in systolic blood pressure

    Measured in mmHg

    Measured: baseline and 3 months

  3. Change in diastolic blood pressure

    Measured in mmHg

    Measured: baseline and 3 months

  4. Change in HbA1c

    Measured in %

    Measured: baseline and 3 months

  5. Change in plasma glucose

    Measured in mmol/l

    Measured: baseline and 3 months

  6. Change in insulin

    Measured in μU/ml

    Measured: baseline and 3 months

  7. Change in lipids-total cholesterol

    Measured in mmol/l

    Measured: baseline and 3 months

  8. Change in lipids-low density lipoprotein cholesterol

    Measured in mmol/l

    Measured: baseline and 3 months

  9. Change in lipids-high density lipoprotein cholesterol

    Measured in mmol/l

    Measured: baseline and 3 months

  10. Change in lipids-triglycerides

    Measured in mmol/l

    Measured: baseline and 3 months

  11. Change in lipids-free fatty acids

    Measured in μmol/l

    Measured: baseline and 3 months

  12. Change in Uric Acid

    Measured in mmol/l

    Measured: baseline and 3 months

  13. Change in interleukin-6

    Measured in mmol/l

    Measured: baseline and 3 months

  14. Change in tumor necrosis factor

    Measured in mmol/l

    Measured: baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start1 Sep 2018
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671733
Sponsor's protocol ID
201806897
Status last verified
Apr 2021
First submitted
12 Sep 2018
Last updated
9 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liraglutide, Exenatide and Exenatide Microspheres for Injection in people with Obesity, run by Xiangya Hospital of Central South University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jing Wu (+86-13574120508, wujing0731@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change at 3 months (time frame: baseline , 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03671733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.

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