GENETIC VARIABILITY TO GLP1 TREATMENT

Obesity Clinical Trial

— GLP1 treatment  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298799
• Other study ID #: GEN-GE-001-IL
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: GENGE
• Contact: Hila Kfir
• Phone: +972-523313350
• Email: hilaz28[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events.

Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit:

• Informed consent

• Study eligibility (Inclusion / Exclusion criteria)

• Collection of demographic data (age (date of birth), gender, ethnic origin)

• General and T2DM medical history review (per subject file)

• Concomitant medication review (at enrollment)

• Physical attributes (Body Weight, Height, BMI)

• Allocation to study cohort and study subgroup

• Saliva and blood collection for genetic tests

• Self-reported questionnaire for Ozempic (Semaglutide) experience

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Genetic:
• DNA Sequencing and Analysis
DNA extracted from saliva / oral mucosa will be tested for diversities reported in the literature known to be associated with T2DM and Obesity and which may have a potential impact on the response to treatment with Semaglutide. In addition, the DNA will be screened for new diversities that have a potential impact on the response to treatment. working assumption of the study is that there can be 3 types of genetic variants that affect the drug's effectiveness and/or side effects.
• differential expression analysis with RNA-sequencing (RNA seq) experiments
Performing small RNA sequencing experiments on an Illumina Next-Generation Sequencing (NGS) machine to investigate microRNAs (miRNAs) or other small non-coding RNAs involves specific steps tailored to the unique characteristics of these molecules

Locations

Country	Name	City	State
Israel	Rambem medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
GENGE

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genetic variants and miRNA expressions associated with side effects.	Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with side effects.	12 months
Other	Demographic parameters that affect GLP1 AG therapy.	To identify demographic parameters that affect the response to GLP1 AG therapy.	12 months
Primary	Genetic variants and miRNA expressions associated with changes in BMI.	Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with changes in BMI.	12 months
Secondary	Genetic variants and miRNA expressions associated with changes in A1c.	Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with changes in A1c.	12 months