Metabolism and Nutrition DisorderPhase 1NCT02717858
A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.
A Phase 1 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the effects of liraglutide on gallbladder emptying in overweight and obese subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- 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
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Mar 2016to 27 Feb 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) equal to or above 27.0 kg/m^2
- Stable body weight (less than 3 kg self-reported change during the previous 3 months)
- Ultrasound assessment of gallbladder volume of an acceptable quality at screening, as judged by the investigator
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or longacting injections))
- History of gastrointestinal surgery or other medical procedure precluding gallbladder emptying assessment (appendectomy is allowed) or any significant digestive disease per the judgement of the investigator
- History of pancreatitis (acute or chronic) or any gallbladder disease (incl. gallstones, gallbladder sludge, or polyps)
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the effects of liraglutide on gallbladder emptying in overweight and obese subjects.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- liraglutide, placebo
- Medical subject headings
- Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Injected s.c./subcutaneously (under the skin) Dose escalation period starting with liraglutide 0.6 mg per day and escalated with weekly increments of 0.6 mg until the target dose 3.0 mg is reached.
placeboDrug
Injected s.c./subcutaneously (under the skin) once daily.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Not described Receives: Drug: liraglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum postprandial gallbladder ejection fraction (GBEFmax)
Measured: At 12 weeks (visit 9)
Secondary outcomes (9)
GBEFmax (maximum gallbladder ejection fraction) after first treatment dose
Measured: At first treatment dose (visit 4, day 2)
Gallbladder volume
Measured: At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)
Gallbladder volume
Measured: At 12 weeks (visit 9)
Area under gallbladder EF-time (ejection fraction) curve
Measured: At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)
Area under gallbladder EF-time curve
Measured: At 12 weeks (visit 9)
Area under the paracetamol concentration-time curve
Measured: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Area under the paracetamol concentration-time curve
Measured: At 12 weeks (visit 9)
Incremental area under the plasma glucose concentration-time curve
Measured: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Incremental area under the plasma glucose concentration-time curve
Measured: At 12 weeks (visit 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start16 Mar 2016
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717858
- Sponsor's protocol ID
- NN8022-4192
- Other IDs
- 2014-004772-38, U1111-1163-4641, 2014
- Status last verified
- Jun 2018
- First submitted
- 15 Mar 2016
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Nexoe-Larsen CC, Sorensen PH, Hausner H, Agersnap M, Baekdal M, Bronden A, Gustafsson LN, Sonne DP, Vedtofte L, Vilsboll T, Knop FK. Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity. Diabetes Obes Metab. 2018 Nov;20(11):2557-2564. doi: 10.1111/dom.13420. Epub 2018 Jul 10.
PubMed 29892986
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02717858
- Acronym / sponsor ID
- NN8022-4192
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 24 Mar 2016 (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 trial is conducted in Europe. The aim of this trial is to investigate the effects of liraglutide on gallbladder emptying in overweight and obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: liraglutide |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) equal to or above 27.0 kg/m^2
- Stable body weight (less than 3 kg self-reported change during the previous 3 months)
- Ultrasound assessment of gallbladder volume of an acceptable quality at screening, as judged by the investigator
Key exclusion criteria (4 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or longacting injections))
- History of gastrointestinal surgery or other medical procedure precluding gallbladder emptying assessment (appendectomy is allowed) or any significant digestive disease per the judgement of the investigator
- History of pancreatitis (acute or chronic) or any gallbladder disease (incl. gallstones, gallbladder sludge, or polyps)
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
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 |
|---|---|---|
| liraglutideInjected s.c./subcutaneously (under the skin) Dose escalation period starting with liraglutide 0.6 mg per day and escalated with weekly increments of 0.6 mg until the target dose 3.0 mg is reached. | Drug | Liraglutide |
| placeboInjected s.c./subcutaneously (under the skin) once daily. | Drug | Placebo |
Primary outcome
Maximum postprandial gallbladder ejection fraction (GBEFmax)
Time frame: At 12 weeks (visit 9)
9 secondary outcomes
GBEFmax (maximum gallbladder ejection fraction) after first treatment dose
Time frame: At first treatment dose (visit 4, day 2)
Gallbladder volume
Time frame: At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)
Gallbladder volume
Time frame: At 12 weeks (visit 9)
Area under gallbladder EF-time (ejection fraction) curve
Time frame: At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)
Area under gallbladder EF-time curve
Time frame: At 12 weeks (visit 9)
Area under the paracetamol concentration-time curve
Time frame: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Area under the paracetamol concentration-time curve
Time frame: At 12 weeks (visit 9)
Incremental area under the plasma glucose concentration-time curve
Time frame: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Incremental area under the plasma glucose concentration-time curve
Time frame: At 12 weeks (visit 9)
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 28 Jun 2018.
- Results publication: PubMed 29892986Nexoe-Larsen CC, Sorensen PH, Hausner H, Agersnap M, Baekdal M, Bronden A, Gustafsson LN, Sonne DP, Vedtofte L, Vilsboll T, Knop FK. Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity. Diabetes Obes Metab. 2018 Nov;20(11):2557-2564. doi: 10.1111/dom.13420. Epub 2018 Jul 10.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 1 site in Denmark.
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 4 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 28 Jun 2018. 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 Denmark. 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?
Maximum postprandial gallbladder ejection fraction (GBEFmax) (time frame: At 12 weeks (visit 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717858, which also lists 1 linked publication.
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 28 Jun 2018.