HealthyPhase 1NCT01550653
Liraglutide Effects on Memory in Healthy Subjects
A Phase 1 study testing liraglutide in people with Healthy, run by University of Luebeck at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- Age 18-35 years
- Body mass index between 19 and 25 kg/m2
- Non-smoker
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Luebeck, Department of Neuroendocrinology
Lübeck, 23538
About this study
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.
- Conditions
- Healthy
- Being tested
- liraglutide, Placebo
- Keywords
- Memory, GLP-1, Liraglutide, energy output, Memory facilitation, GLP-1 analogue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called Victoza
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).
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | See "Intervention" Receives: Drug: liraglutide |
| Placebo | Placebo comparator | See "Intervention" Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
indirect calorimetry
Measured: 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.
Measured: Day -7, 1, 7, 28, 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Dr. med. Volker Ott, University of Luebeck
- Investigators
- Volker Ott, MD, Principal investigator, University of Luebeck, Department of Neuroendocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550653
- Sponsor's protocol ID
- Ott-NN-001
- Status last verified
- Feb 2014
- First submitted
- 1 Mar 2012
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide Effects on Memory in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01550653
- Acronym / sponsor ID
- Ott-NN-001
- Conditions
- Healthy
- Keywords
- Memory, GLP-1, Liraglutide, energy output, Memory facilitation, GLP-1 analogue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: liraglutideSee "Intervention" |
| Placebo | Placebo comparator | Drug: PlaceboSee "Intervention" |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male sex
- Age 18-35 years
- Body mass index between 19 and 25 kg/m2
- Non-smoker
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideAlso: VictozaSubcutaneous 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). | Drug | Liraglutide |
| Placebo | Drug | Placebo |
Primary outcome
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.
Time frame: 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.
Time frame: 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.
Time frame: Day -7, Day 1, Day 35
Change from baseline in performance on a working-memory task on day 1 and day 35.
Time frame: Day -7, Day 1, Day 35
Digit Span Test
Change from baseline in immediate and delayed recall of a procedural memory task at the time points indicated in the "Time Frame" - section.
Time frame: Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)
Finger tapping test
2 secondary outcomes
Change from baseline in resting metabolic rate on day 7, 28 and 35.
Time frame: 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.
Time frame: Day -7, 1, 7, 28, 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Ott, MD principal investigator
University of Luebeck, Department of Neuroendocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing liraglutide in people with Healthy, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.