DelfaGLP-1 Atlas

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GAROS

RecruitingPhase NA

Genetics of the Acute Response to Oral Semaglutide

Genetics of the Acute Response to Oral Semaglutide (GAROS)

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

1,000

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•HbA1c, change•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05340868
Org study IDAPK.002.12.2022

Timeline

Milestones

Study first posted2022-04-22actual
Study start2022-09-01actual
Last update posted2025-03-26actual
Primary completion2025-12-31estimated
Study completion2025-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Informed consent was given before any study-related action on the subject.
•Age: 18-65 years old
•Body mass index (BMI) >30 kg/m2 or >27 kg/m2 when accompanied by prediabetes, diagnosed according to the criteria of the American Diabetes Association

Exclusion criteria

•Patients diagnosed with a serious chronic disease, including:
–Ischemic heart disease
–Heart failure (NYHA class III-IV)
–Severe renal insufficiency (eGFR <30 ml/min)
–Severe liver diseases
–Inflammatory bowel disease
–Diabetic gastroparesis
–Cancer - currently or in the last five years prior to screening
–Chronic obstructive pulmonary disease
–History of mental illness, major depression or other severe mental disorders
•Use of any medications with clinically-proven significant weight gain or loss effects
•History of undergoing bariatric surgery or other surgery involving the stomach that could affect the absorption of the study drug (according to the investigator's opinion)
•History of idiopathic acute pancreatitis
•A family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer
•For women - pregnancy, breastfeeding or planning pregnancy.
•Women of childbearing age who are not using highly effective methods of contraception
•Known or suspected hypersensitivity to the test product

Endpoints (6)

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.

Coverage by outcome category

Weight & body composition
3
Glycemic / diabetes
3

Weight & body composition

3 endpoints
Primary/protocol endpoint

Body composition - change in body weight (kg)

Time frame:1 and 3 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body composition - change in body fat content (kg)

Time frame:1 and 3 months

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Body composition - change in lean body mass content (kg)

Time frame:1 and 3 months

Lean mass

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Glycemic measures - change in HbA1c (%)

Time frame:1 and 3 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Glycemic measures - change in 2-hour glucose (in mg/dl)

Time frame:1 and 3 months

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Glycemic measures - change in fasting glucose (in mg/dl)

Time frame:1 and 3 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.