NCT01550653

Brief Summary

This study examines the hypothesis, that subcutaneous administration of liraglutide, an analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in healthy humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2012

Longer than P75 for phase_1 healthy

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

March 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

1.6 years

First QC Date

March 1, 2012

Last Update Submit

February 26, 2014

Conditions

Healthy

Keywords

MemoryGLP-1Liraglutideenergy outputMemory facilitationGLP-1 analogue

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline in the immediate and delayed recall of a declarative memory task (word list recall) at time points indicated in "time frame" section.

    Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 1 (Immediate Recall 2), Day 7 (Delayed Recall 2), Day 28 (Immediate Recall 3), Day 35 (Delayed Recall 3)

  • Change from baseline in the immediate and delayed recall of an Episodic Memory Task (story recall) at the time points indicated in the "Time Frame" - section.

    Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)

  • Change from baseline in performance on a two-dimensional object location task on day 1 and day 35.

    Day -7, Day 1, Day 35

  • Change from baseline in performance on a working-memory task on day 1 and day 35.

    Digit Span Test

    Day -7, Day 1, Day 35

  • Change from baseline in immediate and delayed recall of a procedural memory task at the time points indicated in the "Time Frame" - section.

    Finger tapping test

    Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)

Secondary Outcomes (2)

  • Change from baseline in resting metabolic rate on day 7, 28 and 35.

    Day 0 , Day 7 , Day 28 , Day 35

  • Change from baseline in serum/plasma concentrations of parameters involved in glucose metabolism on day 1,7,28, and 35.

    Day -7, 1, 7, 28, 35

Study Arms (2)

Liraglutide

EXPERIMENTAL

See "Intervention"

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

See "Intervention"

Drug: Placebo

Interventions

liraglutideDRUG

Subcutaneous self-administration of liraglutide(Victoza)by pen. The starting dose is 0.6 mg once daily(day 0 to 7), followed by 1.2 mg once daily (day 8 to 35).

Also known as: Victoza
Liraglutide
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male sex
  • Age 18-35 years
  • Body mass index between 19 and 25 kg/m2
  • Non-smoker

You may not qualify if:

  • Receipt of any drug within 4 weeks prior to this trial
  • Any known acute or chronic disease of the brain, heart, lung, kidney,liver, pancreas or gastrointestinal tract, any metabolic, endocrine or psychiatric disease.
  • Brady- and Tachycardia, i.e. heart rate \< 50 and \> 90 beats per minute.
  • Hypertension (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 90 mmHg).
  • Hyperlipidemia (cholesterol, LDL, triglyceride \> two times the upper reference limit based on analysis from the central laboratory)
  • Impaired hepatic function measured as alanine aminotransferase (ALAT) \> two times the upper reference limit based on analysis from the central laboratory
  • Impaired renal function measured as creatinine \> 120 µmol/l based on analysis from the central laboratory
  • Family history of diabetes
  • History of any eating disorder
  • Known or suspected allergy to trial products
  • History of drug or alcohol abuse within the last five years prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Luebeck, Department of Neuroendocrinology

Lübeck, 23538, Germany

Location

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Volker Ott, MD

    University of Luebeck, Department of Neuroendocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 12, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

DE(1)