NCT02717858

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2016

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 15, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

March 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

12 months

First QC Date

March 15, 2016

Last Update Submit

June 26, 2018

Conditions

Metabolism and Nutrition DisorderObesity

Outcome Measures

Primary Outcomes (1)

  • Maximum postprandial gallbladder ejection fraction (GBEFmax)

    At 12 weeks (visit 9)

Secondary Outcomes (9)

  • GBEFmax (maximum gallbladder ejection fraction) after first treatment dose

    At first treatment dose (visit 4, day 2)

  • Gallbladder volume

    At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)

  • Gallbladder volume

    At 12 weeks (visit 9)

  • Area under gallbladder EF-time (ejection fraction) curve

    At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)

  • Area under gallbladder EF-time curve

    At 12 weeks (visit 9)

  • +4 more secondary outcomes

Study Arms (2)

Liraglutide

EXPERIMENTAL
Drug: liraglutide

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

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.

Liraglutide
placeboDRUG

Injected s.c./subcutaneously (under the skin) once daily.

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Hellerup, 2900, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29892986RESULT

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 24, 2016

Study Start

March 16, 2016

Primary Completion

February 27, 2017

Study Completion

February 27, 2017

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

DK(1)