Overview

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

Status:
Completed
Trial end date:
2015-01-07
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
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