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
NCT ID: NCT02079870
Last Updated: 2017-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2014-03-06
2015-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sema
Two 12-week treatment periods separated by a wash-out period of 5-7 weeks. Finally, a follow-up visit is performed 5-7 weeks after last dosing
semaglutide
Solution for subcutaneous (s.c. - under the skin) injection. 0.25 mg semaglutide once weekly for four weeks, 0.5 mg semaglutide once weekly for four weeks followed by 1.0 mg semaglutide once weekly for five weeks
Placebo
placebo
Solution for subcutaneous (s.c. - under the skin) injection
Interventions
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semaglutide
Solution for subcutaneous (s.c. - under the skin) injection. 0.25 mg semaglutide once weekly for four weeks, 0.5 mg semaglutide once weekly for four weeks followed by 1.0 mg semaglutide once weekly for five weeks
placebo
Solution for subcutaneous (s.c. - under the skin) injection
Eligibility Criteria
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Inclusion Criteria
* HbA1c (glycosylated haemoglobin A1c) below 6.5%
* A BMI (body mass index) between 30-45 kg/m\^2 (both inclusive)
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Leeds, , United Kingdom
Countries
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References
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Blundell J, Finlayson G, Axelsen M, Flint A, Gibbons C, Kvist T, Hjerpsted JB. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes Obes Metab. 2017 Sep;19(9):1242-1251. doi: 10.1111/dom.12932. Epub 2017 May 5.
Hjerpsted JB, Flint A, Brooks A, Axelsen MB, Kvist T, Blundell J. Semaglutide improves postprandial glucose and lipid metabolism, and delays first-hour gastric emptying in subjects with obesity. Diabetes Obes Metab. 2018 Mar;20(3):610-619. doi: 10.1111/dom.13120. Epub 2017 Oct 27.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2013-000012-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1138-2039
Identifier Type: OTHER
Identifier Source: secondary_id
NN9535-3685
Identifier Type: -
Identifier Source: org_study_id