Assessing genetic factors in response to GLP-1 treatment for diabetes and obesity

RETRO-PROSPECTIVE OPEN STUDY TO ASSES GENETIC VARIABILITY AS A BASIS FOR PREDICTION OF THE RESPONSE TO GLP1 TREATMENT

This study is testing how different genes affect the success of a diabetes and obesity treatment called Ozempic to see who might benefit the most from it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Genge (Academic / other)
• Locations: 1 site (Haifa)
• Trial ID: NCT06298799 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the impact of genetic variability on the effectiveness of GLP-1 treatment, specifically focusing on weight loss and blood sugar reduction in individuals with type 2 diabetes or obesity. Participants will undergo a single visit at a diabetes clinic where they will provide informed consent, undergo eligibility screening, and have their genetic material collected for analysis. The study will analyze genetic variants to identify those who are likely to respond positively to Ozempic (Semaglutide) treatment. The findings could help tailor diabetes and obesity treatments based on genetic profiles.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a diagnosis of type 2 diabetes or obesity who have been treated with Ozempic for at least 24 weeks.

Not a fit: Patients who are contraindicated for Ozempic or have conditions affecting body weight may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies for individuals with type 2 diabetes and obesity, improving their response to GLP-1 therapies.

How similar studies have performed: While the approach of assessing genetic factors in treatment response is gaining traction, this specific study's focus on GLP-1 treatment and genetic variability is relatively novel.

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.

Where this trial is running

Haifa

• Rambem medical center — Haifa, Israel (Recruiting)

Study contacts

• Study coordinator: Hila Kfir

Conditions Type 2 Diabetes; Obesity