GLP-1 for PCOS: What the Trials Show, Off-Label Rules
No GLP-1 label lists polycystic ovary syndrome (PCOS) as an approved use; doctors may still prescribe one when a listed use, such as weight loss, also applies. In SURMOUNT-1, people on Zepbound lost 20.9% of body weight on average, vs 3.1% on placebo.
- Best result (SURMOUNT-1)
- 20.9% weight loss
Weight loss and half-life overview
In days, half-life means how long the body needs to remove half a dose, based on section 12.3 of each FDA label.
This is a percentage of body weight. Trials differed in doses and lengths, so compare each result with the placebo result from that trial's page.
Is GLP-1 approved for 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 |
Sources: FDA label (DailyMed).
Who qualifies?
| Who sets the rule | Who qualifies |
|---|---|
| Ozempic | It lowers blood sugar in adults with type 2 diabetes when combined with diet and exercise. |
| Ozempic | In adults with both heart disease and type 2 diabetes, it lowers the risk of heart attack, stroke, or heart-related death. |
| Ozempic | Among adults who have type 2 diabetes plus chronic kidney disease, it reduces the likelihood of worsening kidney disease, kidney failure, and heart-related death. |
| Wegovy | Among adults with heart disease and obesity or overweight, it reduces the risk of heart attack, stroke, or heart-related death (injection and tablets). |
| Wegovy | When used with diet and activity, it supports weight loss and long-term weight maintenance for children 12 and older with obesity and adults with obesity. It also helps adults with overweight plus a weight-related condition. |
| Wegovy | In adults, it treats MASH liver disease with moderate to advanced scarring (no cirrhosis) (injection). |
| Wegovy | For adults, the label approves tablets to support weight loss and lower heart risk. |
| Rybelsus | It lowers blood sugar in adults with type 2 diabetes when combined with diet and exercise. |
| Rybelsus | Among adults who have type 2 diabetes and face high risk, it lowers the chance of death related to the heart, a heart attack, or stroke. |
| Mounjaro | Taken with diet and exercise, it lowers blood sugar for children age 10 and older and for adults who have type 2 diabetes. |
| Mounjaro | Among adults who have type 2 diabetes and face high risk, it lowers the chance of death related to the heart, a heart attack, or stroke. |
| Zepbound | When paired with diet and activity, it supports long-term weight loss and maintenance for adults with obesity or overweight plus a weight-related condition. |
| Zepbound | For adults with obesity, it treats obstructive sleep apnea that is moderate to severe. |
| Foundayo | When paired with diet and activity, it supports long-term weight loss and maintenance for adults with obesity or overweight plus a weight-related condition. |
| Trulicity | Taken with diet and exercise, it lowers blood sugar for children age 10 and older and for adults who have type 2 diabetes. |
| Trulicity | In adults with both heart disease and type 2 diabetes, it lowers the risk of heart attack, stroke, or heart-related death or several heart risk factors. |
| Saxenda | Children 12 and older weighing over 60 kg can use it, as can adults with obesity and adults who are overweight and also have a weight-related condition. Used with diet and activity, it helps them reach a lower weight and keep it off over the long term. |
| Victoza | Taken with diet and exercise, it lowers blood sugar for children age 10 and older and for adults who have type 2 diabetes. |
| Victoza | In adults with both heart disease and type 2 diabetes, it lowers the risk of heart attack, stroke, or heart-related death. |
| Byetta | It lowers blood sugar in adults with type 2 diabetes when combined with diet and exercise. |
| Medicare GLP-1 Bridge | BMI 35 or higher, no condition needed |
| Medicare GLP-1 Bridge | Eligibility requires a BMI of 30 or higher, plus heart failure, CKD 3a+, or uncontrolled blood pressure |
| Medicare GLP-1 Bridge | Eligibility requires a BMI of 27 or higher, plus prediabetes, PAD, or an earlier heart attack or stroke |
| 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) | a 6-month diet and activity program comes first |
Findings from PCOS trials
None of these trials enrolled only polycystic ovary syndrome (PCOS); the people studied were adults with obesity or overweight, without diabetes, adults with obesity or overweight who do not have type 2 diabetes and adults with obesity, without type 2 diabetes.
| 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 |
| SURMOUNT-1 | Zepbound | Adults with obesity or overweight, without diabetes | 72 weeks | 2,539 | 20.9% weight loss | 3.1% on placebo |
| SURMOUNT-5 | Zepbound | Adults with obesity, without type 2 diabetes | 72 weeks | 751 | 20.2% weight loss | Not listed |
| SCALE Obesity and Prediabetes | Saxenda | Adults with obesity or overweight who do not have type 2 diabetes | 56 weeks | 3,731 | 7.4% weight loss | 3% on placebo |
| ATTAIN-1 | Foundayo | Adults with obesity or overweight, without diabetes | 72 weeks | 3,127 | 11.1% weight loss | 2.1% on placebo |
Trial sources: STEP 1 (FDA label (DailyMed)), SURMOUNT-1 (FDA label (DailyMed)), SURMOUNT-5 (PubMed), SCALE Obesity and Prediabetes (FDA label (DailyMed)), ATTAIN-1 (FDA label (DailyMed)).
What is different with PCOS?
| What changes | What the label says | Labels |
|---|---|---|
| Low Blood Sugar When Combined with Insulin Secretagogues or Insulin | Low blood sugar is more likely when you take this medicine with insulin or a sulfonylurea, so those doses may need to be reduced. | All of them |
| Taken with birth control pills | This may lower the effect of birth control pills for a while. After you begin and after every dose increase, add a barrier method, or use a non-oral method. | Mounjaro, Zepbound and Foundayo |
Warnings come from the FDA DailyMed label.
Coverage for PCOS
Medicare Part D excludes any GLP-1 used only for weight loss.
Those who meet the Medicare GLP-1 Bridge rules can find a Wegovy listing at $50 per month.
When Medicaid covers weight-loss GLP-1s, prior authorization is usually required.
Sources: humana.com, CMS, KFF.
- Ozempic Coupon
- Ozempic Cost
- Ozempic Cost Without Insurance
- Ozempic Cost With Insurance
- Is Ozempic Covered by Insurance? Criteria, Copay, Appeal
- Does Medicare Cover Ozempic? Part D Rules and the GLP-1 Bridge
- Ozempic Patient Assistance
- Cheapest Way to Get Ozempic
- Does Medicaid Cover Ozempic? Criteria, Copay, How to Appeal
Questions to ask your prescriber
- Will this affect my birth control?
- When should I stop before I try to get pregnant?
- If PCOS is the main reason, will my plan likely pay?