GENETIC VARIABILITY TO GLP1 TREATMENT

Last updated: March 1, 2024
Sponsor: GENGE
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Obesity

Diabetes And Hypertension

Treatment

differential expression analysis with RNA-sequencing (RNA seq) experiments

DNA Sequencing and Analysis

Clinical Study ID

NCT06298799
GEN-GE-001-IL
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with type 2 diabetes (for participant in Cohort A) or Obese (for participantin Cohort B) and treated with Ozempic (Semaglutide) S.C. injection for at least 24weeks.
  2. Subject is male/female between 18 to 80 years old (both inclusive) at the time ofenrollment.
  3. Subject BMI above 30 kg/m2 at treatment initiation.
  4. Subject does not belong to any vulnerable population, is willing and able to providewritten informed consent prior to any study procedure.
  5. Participant understands the nature of the procedure and is willing and able to complywith all requirement of the protocol.

Exclusion

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, orallergic 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 withinthe 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 thannormal upper limit).
  9. Any disorder, which in the investigator's opinion might jeopardize patient's safety orcompliance with the protocol.
  10. Subject is a female who is pregnant, breastfeeding or intends to become pregnant or isof child bearing potential without medically acceptable methods of contraception.
  11. Participation in another clinical study in prior 4 weeks.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: differential expression analysis with RNA-sequencing (RNA seq) experiments
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
January 01, 2025

Connect with a study center

  • Rambem medical center

    Haifa,
    Israel

    Active - Recruiting

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