- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02079870
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
November 30, 2017 updated by: Novo Nordisk A/S
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
This trial is conducted in Europe.
The aim of the trial is to investigate the effect of semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride metabolism and gastric emptying in obese subjects compared with placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leeds, United Kingdom, LS2 9LH
- Novo Nordisk INvestigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Solution for subcutaneous (s.c. - under the skin) injection
|
Experimental: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ad libitum energy intake during a lunch meal (following a standardised breakfast meal)
Time Frame: After 12 weeks of treatment
|
After 12 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After 12 weeks of treatment during a standardised meal test day
|
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
|
After 12 weeks of treatment during a standardised meal test day
|
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
|
After 12 weeks of treatment during a standardised meal test day
|
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
|
After 12 weeks of treatment during a standardised meal test day
|
Incidence of adverse events
Time Frame: From baseline to follow-up (5-7 weeks after last trial drug administration)
|
From baseline to follow-up (5-7 weeks after last trial drug administration)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2014
Primary Completion (Actual)
January 7, 2015
Study Completion (Actual)
January 7, 2015
Study Registration Dates
First Submitted
March 4, 2014
First Submitted That Met QC Criteria
March 4, 2014
First Posted (Estimate)
March 6, 2014
Study Record Updates
Last Update Posted (Actual)
December 2, 2017
Last Update Submitted That Met QC Criteria
November 30, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9535-3685
- 2013-000012-24 (EudraCT Number)
- U1111-1138-2039 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on semaglutide
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, India, Japan, Russian Federation, United Kingdom, Canada, Spain, South Africa, Germany, Greece, United Arab Emirates, Argentina, Puerto Rico
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2Germany
-
Novo Nordisk A/SCompletedType 2 Diabetes | Healthy VolunteersUnited States, Canada
-
Novo Nordisk A/SActive, not recruitingDiabetes Mellitus, Type 2 | Peripheral Arterial DiseaseSpain, Taiwan, China, India, United States, Canada, Thailand, Austria, Malaysia, Germany, Poland, Japan, Czechia, Greece, Belgium, Denmark, Hungary, Latvia, Norway, Sweden
-
Novo Nordisk A/SCompletedObesityUnited States, Israel, United Kingdom, Denmark, Germany, Netherlands, Canada, Argentina, Czechia, Hungary, Poland, Spain, Australia
-
Novo Nordisk A/SCompletedObesity | Diabetes Mellitus, Type 2 | OverweightKorea, Republic of, Hong Kong, Brazil, China
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, Italy, Spain, Canada, Hungary
-
Novo Nordisk A/SCompletedObesity | OverweightJapan, Korea, Republic of
-
Novo Nordisk A/SCompletedOverweight or Obesity | Metabolism and Nutrition DisorderUnited States, India, Mexico, Russian Federation, United Kingdom, Canada, Denmark, Finland, Belgium, Japan, Taiwan, France, Poland, Germany, Bulgaria, Argentina, Puerto Rico