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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00978393
Other study ID # NN8022-3630
Secondary ID 2008-003228-44U1
Status Completed
Phase Phase 1
First received September 15, 2009
Last updated July 25, 2017
Start date September 16, 2009
Est. completion date June 8, 2011

Study information

Verified date July 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date June 8, 2011
Est. primary completion date June 8, 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
liraglutide
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.
liraglutide
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.
liraglutide
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.
liraglutide
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.
liraglutide
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.
liraglutide
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.

Locations

Country Name City State
Netherlands Novo Nordisk Investigational Site Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van Can J, Sloth B, Jensen CB, Flint A, Blaak EE, Saris WH. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. Int J Obes (Lond). 2014 Jun;38(6):784-93 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles after 35 days of treatment
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