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Delfa

← All trials/NCT06298799

GLP1 treatment

UnknownPhase NA

GENETIC VARIABILITY TO GLP1 TREATMENT

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

Lead sponsor

GENGE

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

400

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

BMI ≥30

Primary endpoint

Genetic variants and miRNA expressions associated with changes in BMI

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06298799
Org study IDGEN-GE-001-IL

Timeline

Milestones

Study start2023-10-01actual
Study first posted2024-03-07actual
Last update posted2024-03-07actual
Primary completion2025-01-01estimated
Study completion2025-01-01estimated

Assets

Investigational agents

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Genetic variants and miRNA expressions associated with changes in BMI.

Time frame:12 months

descriptive

Secondary/protocol endpoint

Genetic variants and miRNA expressions associated with changes in A1c.

Time frame:12 months

descriptive

Other/protocol endpoint/low confidence

Genetic variants and miRNA expressions associated with side effects.

Time frame:12 months

descriptive

Other/protocol endpoint/low confidence

Demographic parameters that affect GLP1 AG therapy.

Time frame:12 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.