Effect of Liraglutide on Microbiome in Obesity

This is an interventional treatment trial for Obesity focused on measuring obesity, liraglutide, gut microbiome Read More

Inclusion Criteria:

1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial;
2. Age ≥ 18 years and < 65 years at the time of signing informed consent;
3. Body mass index (BMI) ≥ 30 kg/m2
4. Stable body weight during the previous 3 months (< 5 kg self-reported weight change).

Exclusion Criteria:

General Safety

1. Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial;
2. Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate or phentermine;
3. Type 1 diabetes;
4. Type 2 diabetes;
5. Obesity related to endocrine diseases;
6. Hepatic Failure (AST and/or ALT >3 times upper limit of normal and/or Total Bilirubin >1.7 upper limit of normal)
7. End stage renal disease (eGFR < 30 ml/min/1.73 m2 ) or chronic or intermittent haemodialysis or peritoneal dialysis
8. History or presence of chronic pancreatitis
9. Presence of acute pancreatitis within the past 180 days prior to the day of screening
10. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
11. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening
12. Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol
13. Known or suspected hypersensitivity to trial product(s) or related products
14. Previous participation in this trial. Participation is defined as randomisation
15. Receipt of any investigational medicinal product within 30 days before screening

16. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method i.e.:

    • patients who use combined hormonal contraceptives (containing estreogen and progesterone) associated with inhibition of ovulation or oral, intravaginal that transdermal;
    • patients who use hormonal contraceptives based only progesterone that inhibit ovulation, whether oral, injectable or implantable
    • patients with placement of IUD (intrauterine device)
    • patients with positioning of hormone releasing intrauterine systems
    • patients with bilateral tubal occlusion
    • patients with vasectomized partner
    • patients who practice sexual abstinence
17. Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the protocol
18. Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry); 19 ) Inflammatory bowel diseases; 20 ) recent antibiotic therapy ( within 30 days before screening)

Cardiovascular- related

• Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening;
• Presently classified as being in New York Heart Association (NYHA) Class IV heart failure