Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
liraglutide-depot · 1 trial · 3 indications
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Liraglutide-depot is an investigational small molecule being developed by Novo Nordisk A/S (NVO) for the treatment of diabetes. It is currently in Phase 1 clinical development, meaning it is still being studied and is not yet approved for any use.
Liraglutide-depot is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for diabetes.
Liraglutide-depot is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and pharmacokinetics in humans.
Liraglutide-depot has one completed Phase 1 clinical trial registered as NCT01473953, titled "Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects." The trial enrolled 31 participants in the United States and was a randomized, double-blind, placebo-controlled study.
Liraglutide-depot is a distinct drug candidate from liraglutide, though it shares a similar name. It is being developed separately by Novo Nordisk A/S for diabetes. The "depot" designation suggests a different formulation, but no additional details are available.