Liraglutide: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Liraglutide appears in the FDA drug-label database. Marketed as Liraglutide.
- Drug class
- GLP-1 Receptor Agonist (FDA established pharmacologic class)
- Mechanism of action
- Glucagon-like Peptide-1 (GLP-1) Agonists (as stated on the FDA label)
- Boxed warning
- The FDA label for Liraglutide carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Liraglutide injection is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus Limitations of Use: Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus ( 1 ). Limitations of Use : Coadministration with other liraglutide-containing products is not recommended.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. — Novo Nordisk Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-22 |
| Presence of particulate matter: a white thread-like structure in the cartridge — Lupin Pharmaceuticals Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2026-04-24 |
| Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. — Novo Nordisk Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-22 |
| Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. — Novo Nordisk Inc | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2021-03-22 |
Phase breakdown
Conditions being studied
Recruiting trials involving Liraglutide
- Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
- Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control
- Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected)
- Liraglutide Treatment in Patients With Maturity-onset Diabetes of the Young (MODY)
- Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD)
- Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus
Common questions
Is Liraglutide FDA-approved?
Yes, marketed as Liraglutide. Its FDA label carries a boxed warning.
How many recruiting trials involve Liraglutide?
6 recruiting trials across 9 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.