LIRAGLUTIDE
Liraglutide helps patients with type 2 diabetes manage their blood sugar levels alongside improvements in diet and exercise. It is used for both adults and children aged 10 years and older to improve glycemic control. This medication is prescribed as a once-daily injection, though it should not be used in combination with other products containing liraglutide.
How LIRAGLUTIDE Works
This drug works by activating GLP-1 receptors in the pancreas, which stimulates the release of insulin when blood sugar levels are elevated. It also helps lower blood sugar by reducing glucagon secretion and slowing the rate at which the stomach empties. Unlike the natural hormone it mimics, this version is resistant to enzyme breakdown, allowing it to remain active in the body for a longer period.
Details
- Status
- Prescription
- First Approved
- 2024-12-23
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
LIRAGLUTIDE Approval History
What LIRAGLUTIDE Treats
1 indicationsLIRAGLUTIDE is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
LIRAGLUTIDE Boxed Warning
RISK OF THYROID C-CELL TUMORS WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [ see Warnings and Precautions ( 5.1 ), Noncli...
WARNING: RISK OF THYROID C-CELL TUMORS WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [ see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 ) ]. Liraglutide injection is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of liraglutide injection and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with liraglutide injection [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ) . • Liraglutide injection is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors ( 4 , 5.1 ).
LIRAGLUTIDE Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
LIRAGLUTIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LIRAGLUTIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LIRAGLUTIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LIRAGLUTIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
197 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04575844 ZQL008 | 200065 R01DK125330 | Ph 4 | recruiting | Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome |
| NCT02944500 | 2015P000327 | Ph 4 | active not recruiting | Saxenda: Underlying Mechanisms and Clinical Outcomes |
| NCT03856632 LEAF | 20181182 | Ph 4 | active not recruiting | Liraglutide Effect in Atrial Fibrillation |
| NCT05965908 | Liraglutide Polycystic Ovary | Ph 3 | completed | Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome |
| NCT05681299 | AAAU4280 | Ph 4 | recruiting | Effects of GH and Lirglutide on AgRP |
| NCT02674893 GLP1 et Goût | BRINDISI 2013 | Ph 4 | terminated | Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes |
| NCT02721888 LIRA-NAFLD/LIP | VERGES NOVO 2012 | Ph 4 | terminated | Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism |
| NCT07225816 | NN9536-8438 U1111-1323-7355 | Ph 1 | recruiting | 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) |
| NCT05579249 results posted | NN9536-4741 U1111-1263-7301 | Ph 4 | completed | A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America |
| NCT07029009 | 2024-0426 | Ph 2 | recruiting | Liraglutide Treatment in Patients With Maturity-onset Diabetes of the Young (MODY) |
| NCT04775082 | NN8022-4392 U1111-1247-8226, 2020-000546-34 | Ph 3 | active not recruiting | SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity |
| NCT07244003 MESSAGE | HD-LLPHYJ-LC-1 | Ph 4 | recruiting | Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control |
| NCT02516657 results posted | 437619-6 | Ph 3 | completed | Liraglutide in Adolescents With Type 1 Diabetes |
| NCT03158805 results posted | 2017-1579 | Ph 2 | completed | Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated) |
| NCT04881110 STARDUST results posted | 2_0401_2021 | Ph 4 | completed | Liraglutide and Peripheral Artery Disease |
| NCT05268237 | BIOL-001 | Ph 1, Ph 2 | recruiting | Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus |
| NCT03087032 LiraGooD | KYH2017-002 | Ph 4 | recruiting | Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD) |
| NCT04883346 results posted | 10000241 000241-CH | Ph 2 | completed | Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy |
| NCT03555994 results posted | D5670C00022 2017-005081-22 | Ph 2 | completed | A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. |
| NCT02403284 | 028 1593855 | Ph 4 | completed | The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans |
| NCT03182426 | Pro00053082 | Ph 1, Ph 2 | completed | Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM) |
| NCT06438146 LIROH | 2023P002985 K23DK125162 | Ph 4 | recruiting | LIROH - Liraglutide for Obesity in HIV |
| NCT04311411 results posted | 17223 I8F-MC-GPHH | Ph 1 | completed | A Study of Tirzepatide in Overweight and Very Overweight Participants |
| NCT02953665 results posted | U1111-1173-0106 | Ph 2 | completed | Safety and Efficacy of Liraglutide in Parkinson's Disease |
| NCT03672812 | 87650318100005327 | Ph 3 | completed | The Use of Liraglutide in Brain Death |
| NCT02518945 results posted | 1969 | Ph 3 | completed | Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes |
| NCT01722266 results posted | NN1962 | Ph 3 | completed | Liraglutide in the Treatment of Type 1 Diabetes Mellitus |
| NCT03712098 DAL results posted | 831835 | Ph 2 | completed | Daily Liraglutide for Nicotine Dependence |
| NCT03757130 results posted | 20170139 | Ph 1 | completed | Multiple Ascending Dose Study of AMG 598 in Adults With Obesity |
| NCT02960659 results posted | 170013 17-DK-0013 | Ph 1, Ph 2 | completed | Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes |
| NCT03374956 results posted | 17-003449 | Ph 3 | completed | Individualized Obesity Pharmacotherapy |
| NCT02527200 results posted | NN8022-4179 2014-004415-37, U1111-1162-7884 | Ph 3 | completed | Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome |
| NCT04605861 | JSWB-LRG2020-301 | Ph 3 | completed | The Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients |
| NCT04074161 STEP 8 results posted | NN9536-4576 U1111-1233-0977 | Ph 3 | completed | Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity |
| NCT01779362 RISE Adult results posted | RISE Adult 5U01DK094406-02 | Ph 3 | completed | RISE Adult Medication Study |
| NCT05467514 | F-2022-1901-019 | Ph 3 | completed | Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus |
| NCT05444569 | 18449 J2R-MC-YAAC | Ph 1 | completed | A Study of LY3537021 in Healthy Participants |
| NCT04657939 Lean-DM | 265208 18/0005908, 19/WM/0365 | Ph 4 | completed | Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes |
| NCT03172494 DUAL™ I China results posted | NN9068-4148 U1111-1154-6671, CTR20170004 | Ph 3 | completed | A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) |
| NCT03101930 results posted | IRB# 170213 | Ph 4 | completed | Cardiovascular Effects of GLP-1 Receptor Activation |
| NCT02743598 | 23284 | Ph 4 | terminated | Liraglutide for HIV-associated Neurocognitive Disorder |
| NCT02863419 PIONEER 4 results posted | NN9924-4224 2015-005210-30, U1111-1176-6029 | Ph 3 | completed | Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus |
| NCT03523273 results posted | 15-001783 Part B R56DK067071, UL1TR000135 | Ph 2 | completed | Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity |
| NCT05360147 | LICD study | Ph 3 | completed | Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus |
| NCT02765399 results posted | LIRA | Ph 4 | completed | The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis |
| NCT02787551 LixiLan-G results posted | EFC13794 2014-004850-32, U1111-1168-4639 | Ph 3 | completed | Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period |
| NCT02973321 results posted | DRI13940 2016-001328-77, U1111-1179-4786 | Ph 2 | completed | A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus |
| NCT01982630 results posted | 8521-003 | Ph 1 | completed | Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003) |
| NCT03038620 results posted | STU 122015-044 | Ph 4 | completed | Impact of Liraglutide 3.0 on Body Fat Distribution |
| NCT01541215 Ellipse™ results posted | NN2211-3659 2011-002605-29, P/288/2010 | Ph 3 | completed | Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes |
Showing 50 of 197 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LIRAGLUTIDE FDA Label Details
Indications & Usage
LIRAGLUTIDE is indicated for the treatment of Type 2 Diabetes.
WARNING: RISK OF THYROID C-CELL TUMORS WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell ...
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Full clinical data, patents, trials, and competitive landscape for liraglutide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.