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Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
Investigation on Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects. A Randomised, Double-blind, Placebo-controlled Trial Investigating Subcutaneously Single Dose Escalation of a Sustained Release Formulation of Liraglutide Lysine in Healthy Male Subjects
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
31
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 20-35•Male
Primary endpoint
•Treatment-emergent AEs (any)
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (14)
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
14 endpointsNumber of Treatment Emergent Adverse Events (TEAEs)
Time frame:Day 0 and up to 21 days after treatment
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), events | 95% CI |
|---|---|---|
| Cohort 1a: Lira-depot 2.25 mgTotal adverse events (AEs) | 3 | — |
| Serious AE | 0 | — |
| Severe AE | 0 | — |
| Moderate AE | 0 | — |
| Mild AE | 3 | — |
| Fatal AE | 0 | — |
| Cohort 2a: Lira-depot 6.75 mgTotal adverse events (AEs) | 3 | — |
| Serious AE | 0 | — |
| Severe AE | 0 | — |
| Moderate AE | 0 | — |
| Mild AE | 3 | — |
| Fatal AE | 0 | — |
| Cohort 3a: Lira-depot 15 mgTotal adverse events (AEs) | 4 | — |
| Serious AE | 0 | — |
| Severe AE | 0 | — |
| Moderate AE | 0 | — |
| Mild AE | 4 | — |
| Fatal AE | 0 | — |
| Cohort 4a: Lira-depot 30 mgTotal adverse events (AEs) | 21 | — |
| Serious AE | 0 | — |
| Severe AE | 1 | — |
| Moderate AE | 9 | — |
| Mild AE | 11 | — |
| Fatal AE | 0 | — |
| PlaceboTotal adverse events (AEs) | 13 | — |
| Serious AE | 0 | — |
| Severe AE | 0 | — |
| Moderate AE | 1 | — |
| Mild AE | 12 | — |
| Fatal AE | 0 | — |
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame:Day 0 and up to 21 days after treatment
Treatment-emergent AEs (any)
event count, event
Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
Time frame:Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), pmol/L | 95% CI |
|---|---|---|
| Cohort 1a: Lira-depot 2.25 mg | 690 | — |
| Cohort 2a: Lira-depot 6.75 mg | 2141 | — |
| Cohort 3a: Lira-depot 15 mg | 6977 | — |
| Cohort 4a: Lira-depot 30 mg | 40041 | — |
Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
Time frame:Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Tmax
descriptive
Posted result
| Group | Value (geometric_mean), hours | 95% CI |
|---|---|---|
| Cohort 1a: Lira-depot 2.25 mg | 15.13 | — |
| Cohort 2a: Lira-depot 6.75 mg | 8.09 | — |
| Cohort 3a: Lira-depot 15 mg | 13.74 | — |
| Cohort 4a: Lira-depot 30 mg | 10.46 | — |
Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity
Time frame:Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), pmol.h/L | 95% CI |
|---|---|---|
| Cohort 1a: Lira-depot 2.25 mg | 43840 | — |
| Cohort 2a: Lira-depot 6.75 mg | 116935 | — |
| Cohort 3a: Lira-depot 15 mg | 360000 | — |
| Cohort 4a: Lira-depot 30 mg | 1443038 | — |
Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment
Time frame:1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), pmol.h/L | 95% CI |
|---|---|---|
| Cohort 1a: Lira-depot 2.25 mg | 37298 | — |
| Cohort 2a: Lira-depot 6.75 mg | 114101 | — |
| Cohort 3a: Lira-depot 15 mg | 316642 | — |
| Cohort 4a: Lira-depot 30 mg | 1363187 | — |
Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment
Time frame:0 to 168 hours after dosing
AUC₀–∞
concentration, descriptive
Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up
Time frame:Day 0 and Day 21
Immunogenicity (ADA)
descriptive
Posted result
| Group | Value (number), participants | 95% CI |
|---|---|---|
| Cohort 1a: Lira-depot 2.25 mgPositive | 0 | — |
| Negative | 6 | — |
| Cohort 2a: Lira-depot 6.75 mgPositive | 0 | — |
| Negative | 6 | — |
| Cohort 3a: Lira-depot 15 mgPositive | 0 | — |
| Negative | 6 | — |
| Cohort 4a: Lira-depot 30 mgPositive | 0 | — |
| Negative | 5 | — |
| PlaceboPositive | 0 | — |
| Negative | 8 | — |
Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
Time frame:Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Cmax
concentration, descriptive
Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
Time frame:Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Tmax
descriptive
Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity
Time frame:Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
AUC₀–∞
concentration, descriptive
Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment
Time frame:1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose
AUC₀–∞
concentration, descriptive
Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment
Time frame:0 to 168 hours after dosing
AUC₀–∞
concentration, descriptive
Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up
Time frame:Day 0 and Day 21
Immunogenicity (ADA)
descriptive
Provenance
Sources
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.