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GLP-1 receptor agonists are no longer "diabetes drugs that also reduce weight." They are an emerging cardiometabolic class with peer-reviewed efficacy across at least six conditions — and the trial program is expanding. This hub maps the conditions, the evidence, and what is and isn't FDA-approved.
FDA-approved · First-line second step after metformin
A1c reductions of 1.5–2.0% with semaglutide; up to 2.5% with tirzepatide. Trial evidence: SUSTAIN program (sema), SURPASS program (tirz).
FDA-approved · MACE reduction (Wegovy, March 2024)
20% relative reduction in major adverse cardiovascular events in adults with obesity and established CVD. Trial: SELECT (NEJM 2023).
FDA-approved · Zepbound for OSA (December 2024)
First drug ever FDA-approved for OSA. Reduces AHI by ~30 events/hr at 52 weeks. Trial: SURMOUNT-OSA (NEJM 2024).
Off-label · Phase 3 evidence accumulating
SYNERGY-NASH showed MASH resolution in 44–62% of tirzepatide-treated patients at 52 weeks. ESSENCE phase 3 interim positive for semaglutide.
Off-label for weight loss · Strong trial evidence
Semaglutide reduced major kidney events 24% in T2D + CKD. Trial: FLOW (NEJM 2024) — stopped early for efficacy.
Off-label · Mechanism makes biological sense
Insulin resistance is central to PCOS pathophysiology. GLP-1 therapy frequently restores ovulation in patients with weight-related anovulation. Smaller trials supportive.
An FDA-approved indication means the agency has reviewed safety and efficacy data and authorized labeling for that condition. Off-label use is legal, common, and frequently appropriate; it means the medication is prescribed for a condition the FDA has not specifically reviewed for that drug. For GLP-1s, off-label use for PCOS, MASH, and certain other indications is supported by emerging trial data and clinical practice but not by FDA-approved labeling.
Most cash-pay telehealth providers, including those we review, write compounded GLP-1 prescriptions primarily for weight management or to support cardiometabolic health, regardless of which underlying condition the patient also has. A patient with T2D, PCOS, or MASLD considering compounded GLP-1 should discuss with their prescriber whether telehealth, traditional primary care, or specialty care is the right fit for their situation.