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CompletedPhase 1

Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo

A Single-centre, Randomised, Double-blind Two-period Cross-over Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

30

actual

Study population

Obesity / overweight

Key I/E criteria

BMI 30-45HbA1c ≤6.5%

Primary endpoint

Ad libitum energy intake during a lunch meal

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 IDNCT02079870
Org study IDNN9535-3685
Secondary ID2013-000012-24
Secondary IDU1111-1138-2039WHO

Timeline

Milestones

Study first posted2014-03-06estimated
Study start2014-03-06actual
Primary completion2015-01-07actual
Study completion2015-01-07actual
Last update posted2017-12-02actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Male or female, age above or equal to 18 years at the time of signing informed consent
HbA1c (glycosylated haemoglobin A1c) below 6.5%
A BMI (body mass index) between 30-45 kg/m^2 (both inclusive)

Exclusion criteria

Females who are pregnant, breast-feeding or intend to become pregnant or is of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local law or practice, UK requirements: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods together with the use of spermicide, and sexual abstinence)
Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Diagnosis of type 1 or 2 diabetes mellitus
Anticipated change in lifestyle (e.g. eating, exercise or sleeping pattern) during the trial
Use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: 1) within 12 months prior to screening any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers, 2) within 3 months prior to screening use of statins, antihyperlipidemics including fibrates or nicotinic acid and its derivates, 3) supplementation with omega 3 fatty acids from 1 month prior to screening, 4) co-treatment with antihypertensive drugs is allowed if treatment has been stable for at least 1 month prior to screening and treatment should be kept unchanged during the trial
Significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week for females and 28 units of alcohol per week for males (1 unit of alcohol equals ½ pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits)
Smoking or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive cotinine test

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

Other (unclassified)
2
Glycemic / diabetes
1
Cardiometabolic biomarkers
1
Patient-reported / QoL
1
Safety / tolerability / PK
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Incremental area under the 0-300 minutes glucose profile (iAUC0-300min,Glucose) following intake of a standardised breakfast meal

Time frame:After 12 weeks of treatment during a standardised meal test day

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Incremental area under the 0-480 minutes triglyceride profile (iAUC0-480min,TG) following intake of a standardised fat-rich meal

Time frame:After 12 weeks of treatment during a standardised meal test day

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Mean postprandial increase (iAUC30-300min/270 min) in rating of overall appetite score (OAS) using Visual Analogue Scales (VAS) before and up to 300 minutes after intake of a standardised breakfast meal

Time frame:After 12 weeks of treatment during a standardised meal test day

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of adverse events

Time frame:From baseline to follow-up (5-7 weeks after last trial drug administration)

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Ad libitum energy intake during a lunch meal (following a standardised breakfast meal)

Time frame:After 12 weeks of treatment

descriptive

Secondary/protocol endpoint/low confidence

Gastric emptying measured by the area under the 0-300 minutes plasma paracetamol concentration curve (AUC0-300min,para) following intake of a standardised breakfast meal (including 1500 mg paracetamol)

Time frame:After 12 weeks of treatment during a standardised meal test day

concentration, descriptive

Publications (2)

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.

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.