Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01473953 | Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects | PHASE1 | COMPLETED | 31 | — | — | Oct 1, 2011 | Mar 1, 2012 | Mar 23, 2017 | 1 | United States |
TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.
| Arm | Type | Description |
|---|---|---|
| Cohort 1a: Lira-depot 2.25 mg | EXPERIMENTAL | - |
| Cohort 2a: Lira-depot 6.75 mg | EXPERIMENTAL | - |
| Cohort 3a: Lira-depot 15 mg | EXPERIMENTAL | - |
| Cohort 4a: Lira-depot 30 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| liraglutide-depot | DRUG | Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation. |
| placebo | DRUG | Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin). |
Inclusion Criteria: * Body mass index (BMI) between 20 and 35 kg/m\^2 (both inclusive) with a body weight of at least 60 kg * Apart from being obese (BMI above 30 kg/m\^2) the subject has to be considered generally healthy Exclusion Criteria: * Medical history of, or presence of, cancer, diabetes...