DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05236517

CompletedPhase 1

A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity

The Effect of Oral Semaglutide 50 mg Once-daily on Energy Intake, Gastric Emptying, Appetite, Control of Eating and Pharmacokinetics in Participants With Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

60

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-45

Primary endpoint

•Energy intake during ad libitum lunch

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 IDNCT05236517
Org study IDNN9932-4873
Secondary ID2021-003341-38
Secondary IDU1111-1266-4375World Health Organization (WHO)

Timeline

Milestones

Study start2022-02-08actual
Study first posted2022-02-11actual
Primary completion2022-09-29actual
Study completion2022-11-07actual
Last update posted2024-09-19actual

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

•Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
•Body mass index between 30.0 and 45.0 kilogram per meter square (kg/m^2) (both inclusive)

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
•Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol
•Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions

Endpoints (21)

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

Safety / tolerability / PK
11
Patient-reported / QoL
6
Other (unclassified)
2
Weight & body composition
1
Other clinical outcomes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to Day 141

Body weight, % change

percent change from baseline, improvement

Patient-reported / QoL

6 endpoints
Secondary/protocol endpoint

Mean postprandial rating - hunger

Time frame:Day 140

change from baseline, improvement

Secondary/protocol endpoint

Mean postprandial rating - fullness

Time frame:Day 140

descriptive, improvement

Secondary/protocol endpoint

Mean postprandial rating - satiety

Time frame:Day 140

change from baseline, improvement

Secondary/protocol endpoint

Mean postprandial rating - prospective food consumption

Time frame:Day 140

change from baseline, improvement

Secondary/protocol endpoint

Mean postprandial rating - overall appetite score (OAS)

Time frame:Day 140

change from baseline, improvement

Secondary/protocol endpoint

Food cravings assessed by Control of Eating Questionnaire (COEQ)

Time frame:Day 139

descriptive, improvement

Safety / tolerability / PK

11 endpoints
Secondary/protocol endpoint

AUC0-5h,para

Time frame:0-5h after standardised meal, Day 141

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-1h,para

Time frame:0-1h after standardised meal, Day 141

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,para

Time frame:0-5h after standardised meal, Day 141

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,para

Time frame:0-5h after standardised meal, Day 141

Tmax

descriptive

Secondary/protocol endpoint

AUC0-24h,sema,50mg,ss area under these semaglutide-time curve (0-24h) during a dosing interval at steady state

Time frame:Day 140 to 141

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,50mg,ss maximum concentration at steady state of semaglutide 50 mg

Time frame:Day 140 to 175

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,sema,50mg,ss from last dosing to maximum concentration of semaglutide at steady state for semaglutide 50 mg

Time frame:Day 140 to 175

Tmax

descriptive

Secondary/protocol endpoint

t½,sema,50mg,SS terminal half-life of the log concentration time curve

Time frame:Day 140 to 175

Half-life

descriptive

Secondary/protocol endpoint

CL/Fsema,50mg,ss total apparent clearance for semaglutide 50 mg at steady state

Time frame:Day 140 to 175

descriptive

Secondary/protocol endpoint

Vz/Fsema,50mg,ss apparent volume of distribution during elimination for semaglutide 50 mg at steady state

Time frame:Day 140 to 175

descriptive

Secondary/protocol endpoint

Vss/Fsema,50mg,ss apparent volume of distribution at steady state for semaglutide 50 mg

Time frame:Day 140 to 175

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change in amount of food consumed during ad libitum lunch

Time frame:Baseline to Day 140

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Relative change in energy intake during ad libitum lunch

Time frame:Baseline to Day 140

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in energy intake during ad libitum lunch

Time frame:Baseline to Day 140

change from baseline, improvement

Publications (1)

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.