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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079870
• Other study ID #: NN9535-3685
• Secondary ID: 2013-000012-24U1
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2014
• Last updated: November 30, 2017
• Start date: March 6, 2014
• Est. completion date: January 7, 2015

Study information

• Verified date: November 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 7, 2015
• Est. primary completion date: January 7, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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): — View Citation

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. 2017 Sep 23. doi: 10.1111/dom.13120. [E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ad libitum energy intake during a lunch meal (following a standardised breakfast meal)		After 12 weeks of treatment
Secondary	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		After 12 weeks of treatment during a standardised meal test day
Secondary	Incremental area under the 0-300 minutes glucose profile (iAUC0-300min,Glucose) following intake of a standardised breakfast meal		After 12 weeks of treatment during a standardised meal test day
Secondary	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)		After 12 weeks of treatment during a standardised meal test day
Secondary	Incremental area under the 0-480 minutes triglyceride profile (iAUC0-480min,TG) following intake of a standardised fat-rich meal		After 12 weeks of treatment during a standardised meal test day
Secondary	Incidence of adverse events		From baseline to follow-up (5-7 weeks after last trial drug administration)

External Links

•   Clinical Trials at Novo Nordisk