A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this clinical trial is to investigate the effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a two-period, six-sequenced, crossover trial where the trial participant will enter two treatment periods with a wash-out period of 6-8 weeks.

Official Title
-----------------
A Randomised, Placebo-controlled, Double-blind, Incomplete Cross-over Design Trial to Evaluate the Effects of Liraglutide on Gastric Emptying, Energy Expenditure and Appetite, and to Evaluate Liraglutide Pharmacokinetics in Non-diabetic Obese Subjects

Conditions
-----------------
Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: liraglutide
* Drug: liraglutide
* Drug: liraglutide
* Drug: liraglutide
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) between 30.0-40.0 kg/m2 Stable body weight (below 5 kg body weight change during past 3 month) Fasting plasma glucose below 7.0 mmol/L Exclusion Criteria: Presence or history of cancer or any clinically significant cardiac, metabolic, renal, gastrointestinal, hepatic, endocrine, dermatological, haematological, or psychiatric diseases or disorders, considered by the Investigator to have influence of the results of this trial History of chronic pancreatitis or idiopathic acute pancreatitis Current or history of treatment with medications that may cause significant weight gain, within 12 months prior to screening Use of weight lowering pharmacotherapy within the last 3 months prior to trial start Previous or scheduled (during the trial period) surgical treatment for obesity Diagnosed type 1 or type 2 diabetes Smoking habitually as judged by the Investigator Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods if not sterile or post-menopausal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: liraglutide<br>* High dose liraglutide treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.<br>|
| Experimental: B<br> | Drug: liraglutide<br>* Low dose liraglutide treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.<br>|
| Experimental: C<br> | Drug: liraglutide<br>* Low dose liraglutide treatment (1.8 mg) followed by high placebo treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.<br>|
| Experimental: D<br> | Drug: liraglutide<br>* High placebo treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.<br>|
| Experimental: E<br> | Drug: liraglutide<br>* High dose liraglutide treatment (3.0) followed by low placebo treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.<br>|
| Experimental: F<br> | Drug: liraglutide<br>* Low placebo treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol |  | after 35 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles |  | after 35 days of treatment |