GENETIC VARIABILITY TO GLP1 TREATMENT

Launched by GENGE · Mar 1, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Genetic Variability to GLP1 Treatment," is looking to understand how certain genetic differences in people might affect their response to a medication called Ozempic (Semaglutide). This medication is used to help manage type 2 diabetes and obesity by promoting weight loss and lowering sugar levels. The goal of the study is to see if knowing a person's genetic makeup can help predict how well they will do on this treatment, including any side effects they might experience.

To participate in the study, individuals should be between 18 and 80 years old and have either type 2 diabetes or obesity, with a body mass index (BMI) over 30. They must have been using Ozempic for at least 24 weeks. Participants will visit a diabetes clinic where they will provide information about their health, undergo some tests, and give samples of saliva and blood for genetic analysis. It's important to note that certain health conditions, such as severe kidney or liver problems, or a history of major heart issues, may exclude someone from participating. Overall, the study aims to gather valuable information that could help tailor diabetes and obesity treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed with type 2 diabetes (for participant in Cohort A) or Obese (for participant in Cohort B) and treated with Ozempic (Semaglutide) S.C. injection for at least 24 weeks.
• • 2. Subject is male/female between 18 to 80 years old (both inclusive) at the time of enrollment.
• • 3. Subject BMI above 30 kg/m2 at treatment initiation.
• • 4. Subject does not belong to any vulnerable population, is willing and able to provide written informed consent prior to any study procedure.
• • 5. Participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol.
• Exclusion Criteria:
• • 1. Subject falls under contraindications to Ozempic (Semaglutide) label
• • 2. Subject known or suspected for hypersensitivity to any GLP-1RA or related products, or allergic constitution
• • 3. Subjects suffers from any other condition affecting body weight.
• • 4. Subject with history of chronic or acute pancreatitis
• • 5. Subject have a history of a major cardiovascular and/or cerebrovascular disease within the 6 months before screening.
• • 6. Presence or history of malignant neoplasm within 5 years prior to screening day.
• • 7. Subject suffers from any renal impairment (Cr \> 2 mg/dl).
• • 8. Subject suffers from any impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit).
• • 9. Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.
• • 10. Subject is a female who is pregnant, breastfeeding or intends to become pregnant or is of child bearing potential without medically acceptable methods of contraception.
• • 11. Participation in another clinical study in prior 4 weeks.