DelfaGLP-1 Atlas

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DIGRAT

Active not recruiting

Direct Measurement of Microstructure of Ingestive Behaviour After Initiation of GLP-1 Receptor Agonist Treatment at Maximum Dose (DIGRAT)

Direct Measurement of Changes in Food Selection and Intake Behaviour After Using the Maximum Dose of GLP-1 Receptor Agonists

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

140

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI ≥30•Female•Healthy volunteers

Primary endpoints

•Energy Intake from Liquid Meal Consumption•Macrostructure of Ingestive Behaviour•Macrostructure of Ingestive Behaviour (Meal Duration)

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 IDNCT07457424
Org study IDRS21-065

Timeline

Milestones

Study start2022-02-17actual
Study first posted2026-03-09actual
Last update posted2026-05-15actual
Primary completion2026-08-31estimated
Study completion2027-01-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-allSemaglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexFemale
Healthy volunteersAccepted
Sampling methodProbability sample

Study population text

People with BM\>30 who are started GLP-1 for treating obesity and people with BMI\>30 without using internal weight loss measures and no history of GLP-1 analog. Also, healthy people with BMI\>18.5 and \<24.9 are involved in the study.

Inclusion criteria

•Age 18 to 75
–Treatment Group: BMI > 30 kg/m2 and clinically indicated for GLP-1 RA's treatment.
–Controls with obesity (BMI ≥ 30 kg/m2) with no history of GLP-1 RA's treatment.
–Healthy normal weight controls (BMI < 25 kg/m2) with no history of using GLP-1 RAs
•Independently mobile
•Capacity to consent to participate

Exclusion criteria

•Pre-treatment factors impairing the ability to consume meal such as Significant dysphagia
–Gastric outlet obstruction
–Systemic or gastrointestinal condition which may affect food intake or preference
–Pregnancy or lactation (At the beginning of each study visit, a urine pregnancy test will be performed for all female participants).
–Active and significant psychiatric illness including substance misuse
–Significant cognitive or communication issues
–Medications with documented effects on food intake or food preference
–History of significant food allergy and certain dietary restrictions (except for lactose intolerance)

Endpoints (29)

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 clinical outcomes
14
Other (unclassified)
5
Patient-reported / QoL
4
Glycemic / diabetes
2
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Plasma Insulin Concentration

Time frame:Insulin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)

change from baseline, improvement

Secondary/protocol endpoint

Plasma Glucagon Concentration

Time frame:Glucagon concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Plasma Amylin Concentration

Time frame:Amylin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)

concentration, descriptive

Secondary/protocol endpoint

Plasma Leptin Concentration

Time frame:Leptin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)

Leptin, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints
Secondary/protocol endpoint

Subjective Appetite Sensation: Hunger

Time frame:Measured at 3 time points per visit: before the drinkometer test, directly after the drinkometer test, and 30 minutes after the end of the drinkometer test.

descriptive, improvement

Secondary/protocol endpoint/low confidence

Subjective Appetite Sensation: Fullness

Time frame:Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

change from baseline, improvement

Secondary/protocol endpoint

Subjective Appetite Sensation: Desire To Eat

Time frame:Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

descriptive

Secondary/protocol endpoint

Subjective Appetite Sensation: Abdominal Discomfort

Time frame:Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

descriptive, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Plasma GLP-1 Concentration

Time frame:GLP-1 concentrations are measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)

concentration, descriptive

Secondary/protocol endpoint

Subjective Appetite Sensation: Nausea

Time frame:Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

Nausea

descriptive

Other clinical outcomes

14 endpoints
Primary/protocol endpoint/low confidence

Energy Intake from Liquid Meal Consumption

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Macrostructure of Ingestive Behaviour (Rate of Energy Intake)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Macrostructure of Ingestive Behaviour (Meal Duration)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behaviour (Suck Energy Intake)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behaviour (Suck Duration)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behaviour (Suck Rate)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behaviour (Suck Maximal Rate)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behaviour (Burst Number)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behaviour (Burst Duration)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behaviour (Burst Energy Intake)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint/low confidence

Microstructure of Ingestive Behaviour (Burst Rate)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behavior (Number of Sucks per Burst)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint

Microstructure of Ingestive Behaviour (Inter-Burst Intervals)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Primary/protocol endpoint/low confidence

Microstructure of Ingestive Behaviour (Inter-Sucks Intervals)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Macrostructure of Ingestive Behaviour (Number of Sucks)

Time frame:At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks

descriptive

Secondary/protocol endpoint/low confidence

Plasma GIP Concentration

Time frame:GIP concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Plasma PYY Concentration

Time frame:PYY concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)

concentration, descriptive

Secondary/protocol endpoint

Plasma Ghrelin Concentration

Time frame:Ghrelin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Plasma CCK Concentration

Time frame:CCK concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)

concentration, descriptive

Publications (11)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.