Ozempic for PCOS (PMOS): Evidence, Off-Label Access

Ozempic is not FDA approved for polycystic ovary syndrome (PCOS). It is approved for type 2 diabetes, heart risk and kidney disease in type 2 diabetes. Some doctors prescribe it when one of those uses also applies. In STEP 1, people on Wegovy lost 14.9% of body weight on average, vs 2.4% on placebo.

Active ingredient: semaglutide
How it is taken: weekly injection
Approved for: Type 2 diabetes, heart risk and kidney disease in type 2 diabetes
Best result (STEP 1): 14.9% weight loss

Ozempic: key facts

How long it remains in the body

With a half-life of about 1 week, half clears by 7 d, while about 3% remains five half-lives (35 d) later.

Main-study results for weight loss

The SUSTAIN 1 trial ran 30 weeks in people with type 2 diabetes: weight loss was 4.7 kg, against 1.2 kg on placebo.

Prices over time

In US dollars, each monthly figure comes from the maker's price page, which shows the list price and self-pay offers.

Sources: FDA label (DailyMed), healthsystemtracker.org, prnewswire.com 1 2.

Who qualifies?

Ozempic: who qualifies
Who sets the rule	Who qualifies
FDA label	It lowers blood sugar in adults with type 2 diabetes when used with diet and exercise.
FDA label	For adults with type 2 diabetes and heart disease, it reduces the chance of heart attack, stroke or heart-related death.
FDA label	In adults with chronic kidney disease and type 2 diabetes, it reduces the chance of kidney disease worsening, kidney failure, and heart-related death.
Typical commercial plan (Aetna policy)	BMI 30 or higher
Typical commercial plan (Aetna policy)	BMI 27 or higher with a weight-related condition
Typical commercial plan (Aetna policy)	first, you follow a diet and activity program that lasts 6 months

Sources: FDA label (DailyMed), aetna.com.

What PCOS trials found

Adults with obesity or overweight and no diabetes took part in all of these trials, and none enrolled only people with polycystic ovary syndrome (PCOS).

Studies that use the same ingredient (semaglutide)
Trial	Medicine	Who took part	Length	People	Main result	Comparison
STEP 1	Wegovy	Adults with obesity or overweight, without diabetes	68 weeks	1,961	14.9% weight loss	2.4% on placebo
OASIS 4	Wegovy	Adults with obesity or overweight, without diabetes	64 weeks	307	13.6% weight loss	2.4% on placebo

Source for the trial: STEP 1 (FDA label (DailyMed)).

What is different for PCOS?

Polycystic ovary syndrome (PCOS): what the Ozempic label says
What changes	What the label says
Hypoglycemia When Used With Insulin Secretagogues or Insulin	Using it with insulin or a sulfonylurea raises the risk of low blood sugar. The doses of those medicines may need to be lowered.

The FDA labels say this: FDA label (DailyMed).

The label lists these warnings: FDA label (DailyMed).

Coverage for PCOS

A GLP-1 used only for weight loss will not be paid for by Medicare Part D.

Medicaid programs usually require prior authorization when they cover weight-loss GLP-1s.

Sources: humana.com, KFF.

Alternatives for PCOS

How GLP-1 drugs relate to polycystic ovary syndrome (PCOS)
Medicine	For PCOS	How it is taken	Trial result
Ozempic	Not a listed use	weekly injection	Not listed
Wegovy	Not a listed use	weekly injection or daily tablet	14.9% weight loss
Rybelsus	Not a listed use	daily tablet	Not listed
Mounjaro	Not a listed use	weekly injection	Not listed
Zepbound	Not a listed use	weekly injection	20.9% weight loss
Foundayo	Not a listed use	daily tablet	11.1% weight loss
Trulicity	Not a listed use	weekly injection	Not listed
Saxenda	Not a listed use	daily injection	7.4% weight loss
Victoza	Not a listed use	daily injection	Not listed
Byetta	Not a listed use	twice-daily injection	Not listed