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ObesityPhase 2NCT04839237

The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients

A Phase 2 study testing Liraglutide and Liraglutide;metformin in people with Obesity, run by Xiangya Hospital of Central South University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This studay evaluates the effect of liraglutide in the treatment of obese patients ande the influence of genetic factors on the curative effect.Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination. 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 and Liraglutide;metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 Dec 2017to 1 Dec 2021
Phase
Phase 2
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.

China1 site

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

Other trials in China

About this study

This studay evaluates the effect of liraglutide in the treatment of obese patients ande the influence of genetic factors on the curative effect.Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Read the detailed description

Background:The rapid growth of obese or overweight people in the world has become a major social problem. Obese often associated with kinds of metabolic disorders, especially type 2 diabetes, and Liraglutide can effectively reduce weight and improve blood glucose.Previous studies have indicated that most patients will experience different degrees of weight loss after using Liraglutide, but there is also a small number of patients with no significant weight loss.The gene polymorphism among individuals may affect the weight loss effect of Liraglutide.

Objectives：1.To find the relationships between genetic variants and the response of Liraglutide to treatment of obese patients.2.To investigate the effects of Liraglutide on weight, metabolism (blood glucose, blood lipid, uric acid, etc.) and gut microbiota in obese Chinese patients.

Intervention:Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Conditions
Obesity
Being tested
Liraglutide, Liraglutide;metformin
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.

  • Liraglutide;metforminDrug

    Also called Victoza;Glucophage

    The treatment of Liraglutide combined with metformin lasted three months.For Liraglutide,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.For metformin,during three months:0.5g each time, 3 times per day,oral.

Study groups in NCT04839237
Study groupRoleWhat they receive
LiraglutideExperimentalObese patients with HbA1C lower than 9.0%,receive Liraglutide alone for 3 months.
Receives: Drug: Liraglutide
Liraglutide combined with metforminExperimentalObese patients with HbA1C ≥9.0%, receive Liraglutide in combination with metformin for 3 months.
Receives: Drug: Liraglutide;metformin

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 and 3 months

  2. Genotype

    Measured: baseline

Secondary outcomes (13)

  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. Gut microbiota composition

    Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).

    Measured: 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 posted9 Apr 2021
  2. Study start1 Dec 2017
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion1 Dec 2021 (estimated)

Why it stopped: The sponsor decides withdrawn this study.

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04839237
Sponsor's protocol ID
201710832
Status last verified
Apr 2021
First submitted
27 Mar 2018
Last updated
9 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liraglutide and Liraglutide;metformin 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: withdrawn, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change at 3 months (time frame: baseline and 3 months). The study lists 2 primary outcomes in all. 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 NCT04839237.

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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