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Tirzepatide for Prediabetes: Evidence, Eligibility, Coverage

Tirzepatide is not FDA approved for prediabetes. It is approved for type 2 diabetes and heart risk. Some doctors prescribe it when one of those uses also applies. In SURMOUNT-1, people on Zepbound lost 20.9% of body weight on average, vs 3.1% on placebo.

Brands
Mounjaro and Zepbound
Best result (SURMOUNT-1)
20.9% weight loss

Zepbound overview

How long the drug stays in your body
100%50%25%0%05.5 d11 d16.5 d22 d27.5 d50%25%12.5%time after the dose

The half-life is 5 to 6 days: after 5.5 d, half is gone, and about 3% remains after five half-lives, or 27.5 d in all.

Weight loss in its main trial
SURMOUNT-1: 5 mg weekly15%SURMOUNT-1: 10 mg weekly19.5%SURMOUNT-1: 15 mg weekly20.9%Placebo3.1%

In SURMOUNT-1, results after 72 weeks showed 20.9% of body weight, compared with 3.1% on placebo.

Costs over time
202420252026$1,086.37$0List priceSelf-pay

Monthly prices are shown in US dollars, covering the list price and self-pay offers taken from the maker's price page.

Sources: FDA label (DailyMed), Eli Lilly 1 2, cnbc.com.

Who qualifies?

Tirzepatide: who qualifies
Who sets the ruleWho qualifies
MounjaroIt lowers blood sugar in adults and children 10 and older with type 2 diabetes when used with diet and exercise.
MounjaroFor adults with type 2 diabetes who are at high risk, it lowers the risk of stroke and heart attack. It also lowers the risk of death related to the heart.
ZepboundWhen used along with diet and activity, it helps adults with obesity, or overweight adults with a weight-related condition, lose weight and keep it off long term.
ZepboundIt treats moderate to severe obstructive sleep apnea in adults with obesity.
Medicare GLP-1 BridgeBMI 35 or higher, no condition needed
Medicare GLP-1 BridgeA BMI of 30 or higher, along with heart failure, blood pressure that is uncontrolled, or CKD 3a+
Medicare GLP-1 BridgePrediabetes, a past heart attack or stroke, or PAD, plus a BMI 27 or higher
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)for 6 months, a program for diet and activity must come first under

Sources are medicare.gov 1 2, the FDA label (DailyMed) 1 2, and aetna.com.

Trial results for prediabetes

The studies included adults with obesity without diabetes, plus adults who were overweight without diabetes. They also included adults with obesity who did not have type 2 diabetes.

Trials of tirzepatide for Prediabetes
TrialMedicineWho took partLengthPeopleMain resultComparison
SURMOUNT-1 ZepboundAdults with obesity or overweight, without diabetes72 weeks2,53920.9% weight loss3.1% on placebo
SURMOUNT-5 ZepboundAdults with obesity, without type 2 diabetes72 weeks75120.2% weight lossNot listed

Trial sources: SURMOUNT-5 (PubMed) and SURMOUNT-1 (FDA label (DailyMed)).

What is different for people with prediabetes?

Prediabetes notes from the tirzepatide label
What changesWhat the label saysLabels
Low blood sugar with insulin secretagogues or insulinWhen used with insulin or a sulfonylurea, it is more likely to cause low blood sugar, so those doses may need to be lowered.All of them
Taken with insulin or sulfonylureasYour risk of low blood sugar goes up when you take this medicine with insulin or a sulfonylurea, such as glipizide or glimepiride.All of them

From the FDA labels: FDA label on DailyMed.

The label warnings come from the FDA label (DailyMed) on DailyMed.

Coverage for prediabetes

A GLP-1 used only for weight loss gets no payment from Medicare Part D.

The Medicare GLP-1 Bridge lists Zepbound at $50 per month for people who meet its rules.

Medicaid usually requires prior authorization when it covers weight-loss GLP-1s.

Sources: humana.com, CMS, KFF.

Alternatives for prediabetes

GLP-1 medicines and prediabetes
MedicineFor prediabetesHow it is takenTrial result
MounjaroNot a listed useweekly injectionNot listed
ZepboundNot a listed useweekly injection20.9% weight loss
OzempicNot a listed useweekly injectionNot listed
WegovyNot a listed useweekly injection or daily tablet14.9% weight loss
RybelsusNot a listed usedaily tabletNot listed
FoundayoNot a listed usedaily tablet11.1% weight loss
TrulicityNot a listed useweekly injectionNot listed
SaxendaNot a listed usedaily injection7.4% weight loss
VictozaNot a listed usedaily injectionNot listed
ByettaNot a listed usetwice-daily injectionNot listed

Sources: FDA label (DailyMed).

Questions for your prescriber