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

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

liraglutide

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00978393

First Posted

September 15, 2009

Last Updated

July 25, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00978393

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

September 16, 2009 (Actual)

Primary Completion Date

June 8, 2011 (Actual)

Study Completion Date

June 8, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism and Nutrition Disorder, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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.

Primary Outcome Measure Information:

Title

Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol

Time Frame

after 35 days of treatment

Secondary Outcome Measure Information:

Title

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

Time Frame

after 35 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Maastricht

ZIP/Postal Code

6229 ER

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

23999198

Citation

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.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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