From the Guidelines
GLP-1 receptor agonists are FDA-approved for multiple indications, primarily for type 2 diabetes management and weight loss, with semaglutide and liraglutide also approved to reduce cardiovascular risk in patients with type 2 diabetes and established cardiovascular disease. For diabetes, medications like semaglutide (Ozempic), dulaglutide (Trulicity), liraglutide (Victoza), exenatide (Byetta, Bydureon), and tirzepatide (Mounjaro) are approved to improve glycemic control alongside diet and exercise 1. Some key points to consider include:
- The FDA-approved indications for GLP-1 RAs include improving glycemic control in adults with type 2 diabetes, with some agents also approved for cardiovascular risk reduction in patients with established cardiovascular disease 1.
- For weight management, higher doses of semaglutide (Wegovy) and liraglutide (Saxenda) are approved for chronic weight management in adults with BMI ≥30 kg/m² or ≥27 kg/m² with at least one weight-related comorbidity 1.
- These medications work by mimicking the incretin hormone GLP-1, which stimulates insulin secretion, suppresses glucagon release, slows gastric emptying, and reduces appetite through central nervous system effects 1.
- The term "G1P" is not a standard medical abbreviation for an FDA-approved medication class. Key considerations for the use of GLP-1 RAs include:
- Dosing and titration: GLP-1 RAs have different dosing regimens, and titration is often necessary to minimize gastrointestinal side effects 1.
- Contraindications: GLP-1 RAs are contraindicated in patients with a history of serious hypersensitivity reaction, pregnancy or breastfeeding, severe renal impairment or end-stage renal failure, and personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 1.
- Adverse effects: GLP-1 RAs can cause nausea, vomiting, diarrhea, headache, weakness, and dizziness, as well as increased risk of hypoglycemia when used with insulin, sulfonylureas, or glinides 1.
From the FDA Drug Label
MOUNJARO® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. VICTOZA 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 • to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease
The FDA approved indications for GLP-1 and GIP are:
- GLP-1:
- Improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus
- Reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease
- GIP: Improve glycemic control in adults with type 2 diabetes mellitus, as part of a dual GIP and GLP-1 receptor agonist 2, 2
From the Research
FDA Approved Indications for GLP-1 and GLP-1 Receptor Agonists
- The FDA has approved several GLP-1 receptor agonists, including exenatide, lixisenatide, liraglutide, dulaglutide, albiglutide, and semaglutide, for the treatment of type 2 diabetes 3, 4, 5, 6, 7.
- These medications are indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes 3, 5, 7.
- Semaglutide, in particular, has been approved as a oral GLP-1 receptor agonist, providing an alternative to injectable formulations for patients who require treatment intensification after oral therapy or as add-on to insulin 5, 6, 7.
Specific Indications for Semaglutide
- Semaglutide has been approved for use as a second-line treatment option for better glycemic control in type 2 diabetes 5.
- It has also been shown to have cardiovascular benefits, reducing the risk of major adverse cardiovascular events such as myocardial infarction, stroke, and death 4, 5.
- Additionally, semaglutide has been found to be effective in reducing body weight and improving renal outcomes in patients with type 2 diabetes 3, 5, 6.
Administration and Dosage
- Semaglutide is available in both subcutaneous and oral dosage forms, with the oral formulation being the first approved oral GLP-1 receptor agonist 5, 7.
- The recommended dosage of semaglutide varies depending on the formulation and individual patient needs, with typical dosages ranging from 0.5 to 1 mg per week for the subcutaneous formulation and 7 to 14 mg per day for the oral formulation 4, 6.