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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00978393

NN8022-3630

U1111-1111-9119 (Other Identifier)

2008-003228-44 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

49 participants in 6 patient groups

A

Experimental group

Treatment:

Drug: liraglutide

B

Experimental group

Treatment:

Drug: liraglutide

C

Experimental group

Treatment:

Drug: liraglutide

D

Experimental group

Treatment:

Drug: liraglutide

E

Experimental group

Treatment:

Drug: liraglutide

F

Experimental group

Treatment:

Drug: liraglutide

Trial contacts and locations

1

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