Is Mounjaro Approved for Weight Loss? Label, BMI Rules, Coverage
Mounjaro is not FDA approved for weight loss. It is approved for type 2 diabetes and heart risk. Zepbound, with the same ingredient, is approved for weight loss. In SURMOUNT-1, people on Zepbound lost 20.9% of body weight on average, vs 3.1% on placebo.
- For weight loss
- Not an approved use
- Active ingredient
- tirzepatide
- How it is taken
- weekly injection
- Best result (SURMOUNT-1)
- 20.9% weight loss
Mounjaro in brief
Its half-life is about 5 days. After 5 d, half is gone, and about 3% remains after five half-lives (25 d).
In SURPASS-1, people with type 2 diabetes lost 7.8 kg over 40 weeks, while the placebo group lost 1 kg.
In US dollars, monthly price points: list price and self-pay offers, each taken from the maker's price listing.
Sources: FDA label (DailyMed), healthsystemtracker.org, pricinginfo.lilly.com.
Who qualifies?
| Who sets the rule | Who qualifies |
|---|---|
| FDA label | For anyone with type 2 diabetes who is 10 and older, it lowers blood sugar when used along with diet and exercise. |
| FDA label | In adults with type 2 diabetes who are at high risk, the risk of Heart attack, stroke, or heart-related death becomes lower. |
| 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 comes a diet and activity program that lasts 6 months |
Sources: aetna.com and the FDA label (DailyMed).
Weight loss trial results
In this group, Mounjaro does not have a trial of its own. The trials here cover other brands that use the same ingredient.
| Trial | Medicine | Who took part | Length | People | Main result | Comparison |
|---|---|---|---|---|---|---|
| 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 |
The sources for these trials are SURMOUNT-1 (FDA label (DailyMed)) and SURMOUNT-5 (PubMed).
What changes when it is used for weight loss?
| What changes | What the label says |
|---|---|
| Acute Pancreatitis | Can cause inflammation of the pancreas. If severe stomach pain does not go away, stop taking it and seek care. Sometimes the pain reaches your back. |
| Acute Gallbladder Disease | Gallstones and gallbladder inflammation can happen. Report upper right belly pain, a fever, or yellow skin or eyes. |
According to the FDA labels: FDA DailyMed label.
The label warnings are found in the FDA DailyMed label.
Coverage for weight loss
If a GLP-1 is used only for weight loss, Medicare Part D will not cover it.
Where Medicaid covers weight-loss GLP-1s, prior authorization is the norm.
Sources are humana.com and KFF.
- Mounjaro Coupon and Savings Card
- Mounjaro Price
- Cheapest Way to Get Mounjaro
- Mounjaro Cost Without Insurance
- Mounjaro Cost With Insurance
- Mounjaro Insurance Coverage
- Does Medicare Cover Mounjaro? Part D Rules, the Bridge, Copays
- Does BCBS Cover Mounjaro? Diabetes-Only Rules by Plan, Appeals
- Mounjaro Patient Assistance
For weight loss
| Medicine | For weight loss | How it is taken | Trial result |
|---|---|---|---|
 Wegovy | FDA approved | weekly injection or daily tablet | 14.9% weight loss |
| Zepbound | FDA approved | weekly injection | 20.9% weight loss |
 Foundayo | FDA approved | daily tablet | 11.1% weight loss |
 Saxenda | FDA approved | daily injection | 7.4% weight loss |
 Mounjaro | Not an approved use | weekly injection | Not listed |
 Ozempic | Not an approved use | weekly injection | Not listed |
 Rybelsus | Not an approved use | daily tablet | Not listed |
 Trulicity | Not an approved use | weekly injection | Not listed |
 Victoza | Not an approved use | daily injection | Not listed |
| Byetta | Not an approved use | twice-daily injection | Not listed |
Sources: FDA DailyMed label.
Questions to ask your prescriber
- Does my weight meet the rule in the label, and does my plan add a weight rule of its own?
- Among the weight-related conditions in my record, which ones qualify?
- By the first year's end, how much weight loss should I expect?
- What happens if I stop taking it?
Read the DailyMed prescribing information for Mounjaro in full.