CompletedPhase 1

Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

A Randomised, Open-label, Single-centre, Two-period, Cross-over Trial Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥27•HbA1c ≤6.5%

Primary endpoints

•AUC of liraglutide from 0 to last quantifiable observation (tz) after single•Maximum observed liraglutide plasma concentration after single dose

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02207348

Org study IDNN8022-4162

Secondary ID2014-000216-34

Secondary IDU1111-1152-1391WHO

Timeline

Milestones

Study first posted2014-08-04estimated

Last update posted2016-12-09estimated

Study start2014-08 (month precision)

Primary completion2014-09actual (month precision)

Study completion2014-09actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age 18-60 years (both inclusive) at the time of signing informed consent

•Body mass index (BMI) greater than or equal to 27.0 and less than 35.0 kg/m^2

•Bodyweight up to 130.0 kg (inclusive)

•HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner

•History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial, as judged by the investigator

•Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial defined as screening

•Significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine (120 mL), or 20 mL spirits)

•Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods

Endpoints (3)

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.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose

Time frame:0-72 hours following administration of 0.6 mg liraglutide

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Maximum observed liraglutide plasma concentration after single dose

Time frame:0-72 hours following administration of 0.6 mg liraglutide

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.