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Recruiting

The Effect of Pharmacotherapy With GLP-1 and GIP/GLP-1 Analogs on Changes in Qualitative and Quantitative Parameters of the Diet as Well as Metabolic and Behavioral Parameters in Patients With Excess Body Weight

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Estimated enrollment

100

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Body weight

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 IDNCT07270497
Org study IDKB/136/2025

Timeline

Milestones

Study start2025-08-15actual
Study first posted2025-12-08actual
Last update posted2025-12-08actual
Primary completion2026-08-14estimated
Study completion2026-08-14estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted
Sampling methodProbability sample

Study population text

People diagnosed with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with comorbidities associated with excess body weight (including type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease), eligibilited for treatment with GLP-1 or GIP/GLP-1 analogues.

Inclusion criteria

•Age 18-65 years,
•Diagnosed obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with comorbidities associated with excess body weight (including type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease),
•Eligibility for treatment with GLP-1 or GIP/GLP-1 analogues,
•Not taking GLP-1 and GIP/GLP-1 analogue medications for at least one year prior to study enrollment,
•Ability to provide informed consent,
•Informed consent to participate in the study.

Exclusion criteria

•Age under 18 or over 65 years,
•Inability to qualify for treatment with GLP-1 and GIP/GLP-1 analogues,
•Pregnancy or breastfeeding,
•Diagnosed eating disorders,
•Active cancer or gastrointestinal conditions that may affect the absorption or tolerance of treatment (e.g., inflammatory bowel disease, conditions after extensive gastrointestinal resections, conditions after bariatric surgery),
•Inability to participate in regular follow-up visits,
•Inability to provide informed consent,
•Failure to provide informed consent to participate in the study.

Endpoints (32)

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

Other (unclassified)
18
Glycemic / diabetes
5
Patient-reported / QoL
5
Weight & body composition
2
Renal / kidney
1
Cardiometabolic biomarkers
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

change in body weight

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in total fat mass

Time frame:12 months

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

Change in HbA1c

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting plasma glucose

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting insulin concentration

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in HOMA-IR

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in diabetes treatment

Time frame:12 months

change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Change in liver enzymes and creatinine

Time frame:12 months

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change in lipid profile

Time frame:12 months

change from baseline, improvement

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

Change in sweet taste preference (VAS)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in preference for high-fat foods (VAS)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in preference for salty foods (VAS)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in preference for meat-based products (VAS)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in preference for fresh/fruit-based foods (VAS)

Time frame:12 months

change from baseline, improvement

Other (unclassified)

18 endpoints
Secondary/protocol endpoint/low confidence

Change in lean body mass

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in percent body fat

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in daily energy intake

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in antihypertensive treatment

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in daily carbohydrate intake

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in daily fat intake

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in daily protein intake

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in diet quality score (KomPAN)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in frequency of consumption of selected food groups

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in emotional eating score (TFEQ-R18)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in uncontrolled eating score (TFEQ-R18)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in cognitive restraint score (TFEQ-R18)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in subjective hunger (VAS)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in subjective satiety (VAS)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in risk of inadequate nutrient intake

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in meal frequency

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in mean daily step count

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in handgrip strength

Time frame:12 months

change from baseline, improvement

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.