NCT00978393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

September 16, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2011

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1.7 years

First QC Date

September 15, 2009

Last Update Submit

July 25, 2017

Conditions

Metabolism and Nutrition DisorderObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles

    after 35 days of treatment

Study Arms (6)

A

EXPERIMENTAL
Drug: liraglutide

B

EXPERIMENTAL
Drug: liraglutide

C

EXPERIMENTAL
Drug: liraglutide

D

EXPERIMENTAL
Drug: liraglutide

E

EXPERIMENTAL
Drug: liraglutide

F

EXPERIMENTAL
Drug: liraglutide

Interventions

liraglutideDRUG

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.

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Maastricht, 6229 ER, Netherlands

Location

Related 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. doi: 10.1038/ijo.2013.162. Epub 2013 Sep 3.

    PMID: 23999198RESULT

Related Links

MeSH Terms

Conditions

Nutrition DisordersObesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

September 16, 2009

Primary Completion

June 8, 2011

Study Completion

June 8, 2011

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

NL(1)