DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02717858

CompletedPhase 1

A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

52

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Gallbladder event

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02717858
Org study IDNN8022-4192
Secondary ID2014-004772-38
Secondary IDU1111-1163-4641WHO

Timeline

Milestones

Study start2016-03-16actual
Study first posted2016-03-24estimated
Primary completion2017-02-27actual
Study completion2017-02-27actual
Last update posted2018-06-28actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
8
Glycemic / diabetes
2

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

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)

Postprandial glucose

descriptive

Secondary/protocol endpoint

Incremental area under the plasma glucose concentration-time curve

Time frame:At 12 weeks (visit 9)

Postprandial glucose

concentration, improvement

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Maximum postprandial gallbladder ejection fraction (GBEFmax)

Time frame:At 12 weeks (visit 9)

Gallbladder event

descriptive

Secondary/protocol endpoint

GBEFmax (maximum gallbladder ejection fraction) after first treatment dose

Time frame:At first treatment dose (visit 4, day 2)

Gallbladder event

descriptive

Secondary/protocol endpoint

Gallbladder volume

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

Gallbladder event

descriptive

Secondary/protocol endpoint

Gallbladder volume

Time frame:At 12 weeks (visit 9)

Gallbladder event

descriptive

Secondary/protocol endpoint

Area under gallbladder EF-time (ejection fraction) curve

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

descriptive

Secondary/protocol endpoint

Area under gallbladder EF-time curve

Time frame:At 12 weeks (visit 9)

descriptive

Secondary/protocol endpoint

Area under the paracetamol concentration-time curve

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under the paracetamol concentration-time curve

Time frame:At 12 weeks (visit 9)

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.