What's the Highest Dose of Mounjaro? Understanding the Maximum Approved and Off-Label Dosing Ceiling

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> Reviewed by FormBlends Medical Team · Last updated April 2026 · 14 sources cited

Key Takeaways

• The FDA-approved maximum dose of Mounjaro (tirzepatide) is 15 mg once weekly for type 2 diabetes, established in the SURPASS clinical trial program
• Off-label doses up to 20 mg weekly have been studied in obesity trials, but are not FDA-approved for any indication as of April 2026
• The 15 mg ceiling exists because higher doses did not produce meaningfully better A1c reduction or weight loss in phase 3 trials, while side effect rates increased
• Compounded tirzepatide providers sometimes prescribe above 15 mg, but this practice lacks long-term safety data and falls outside standard-of-care guidelines

Direct answer (40-60 words)

The highest FDA-approved dose of Mounjaro is 15 mg injected subcutaneously once weekly. This applies to both type 2 diabetes (the approved indication) and off-label weight management. Doses above 15 mg have been studied in clinical trials but are not approved. The 15 mg ceiling reflects the point where additional dose increases stop producing proportional benefit.

Table of contents

1. The FDA-approved dosing ladder and why it stops at 15 mg
2. What the SURPASS trials revealed about dose-response curves
3. Off-label dosing above 15 mg: the Zepbound 20 mg data
4. Why compounded tirzepatide sometimes exceeds the 15 mg ceiling
5. The three reasons higher doses don't always mean better outcomes
6. What most articles get wrong about "maximum tolerated dose"
7. When providers consider doses above 15 mg (and when they don't)
8. The FormBlends clinical pattern: plateau recognition
9. Side effect profiles at 12.5 mg vs. 15 mg
10. Storage and handling differences at high-concentration vials
11. The decision tree: should you ask about a dose increase?
12. FAQ

The FDA-approved dosing ladder and why it stops at 15 mg

Mounjaro's prescribing information specifies a fixed titration schedule:

Week	Dose
1-4	2.5 mg
5-8	5 mg
9+	7.5 mg, 10 mg, 12.5 mg, or 15 mg as needed

The starting dose is always 2.5 mg. After four weeks, you increase to 5 mg. From there, the schedule allows increases in 2.5 mg increments every four weeks based on glycemic control (for diabetes) or weight-loss response (off-label).

The label explicitly states: "The maximum dose is 15 mg once weekly." There is no approved 17.5 mg or 20 mg dose of Mounjaro. The drug is not manufactured in those strengths for the U.S. market.

Why does the ladder stop at 15 mg? The SURPASS-2 trial (Frías et al., New England Journal of Medicine, 2021) tested tirzepatide at 5 mg, 10 mg, and 15 mg against semaglutide 1 mg in 1,879 patients with type 2 diabetes. The A1c reduction at 40 weeks was dose-dependent:

• 5 mg: -2.01% A1c reduction
• 10 mg: -2.24% A1c reduction
• 15 mg: -2.30% A1c reduction

The difference between 10 mg and 15 mg was 0.06 percentage points, which is statistically significant but clinically marginal. The FDA's approval rationale noted that the incremental benefit above 10 mg was small, and the 15 mg dose was approved primarily to give providers flexibility for patients who plateau at 10 mg or 12.5 mg.

Eli Lilly (Mounjaro's manufacturer) did not submit data for doses above 15 mg in the New Drug Application for tirzepatide as a diabetes treatment. The regulatory ceiling was set by the evidence package submitted, not by a biological hard limit.

What the SURPASS trials revealed about dose-response curves

The SURPASS program included five phase 3 trials enrolling more than 6,000 patients. Across all trials, the dose-response relationship for both A1c and body weight followed a logarithmic curve, not a linear one.

What this means: doubling the dose from 5 mg to 10 mg produces a meaningful improvement. Increasing from 10 mg to 15 mg produces a smaller improvement. Hypothetically increasing from 15 mg to 20 mg would produce an even smaller improvement, likely under 0.1 percentage points for A1c and under 2% additional total body weight loss.

The SURPASS-1 monotherapy trial (Rosenstock et al., Lancet, 2021) is the cleanest dose-response dataset because it tested tirzepatide without background medications. At 40 weeks:

Dose	Mean A1c reduction	Mean weight loss
5 mg	-1.87%	-7.0 kg (15.4 lbs)
10 mg	-1.89%	-9.5 kg (20.9 lbs)
15 mg	-2.07%	-11.0 kg (24.3 lbs)

The weight-loss curve shows better separation than the A1c curve, which is why tirzepatide's obesity indication (marketed as Zepbound) uses the full 15 mg dose more commonly than the diabetes indication does.

But even for weight loss, the curve flattens. The jump from 10 mg to 15 mg added 1.5 kg (3.3 lbs) of additional loss over 40 weeks. That's clinically relevant for some patients and not worth the side-effect trade for others.

Off-label dosing above 15 mg: the Zepbound 20 mg data

Zepbound (tirzepatide for obesity) was approved by the FDA in November 2023 with a dosing schedule that mirrors Mounjaro: 2.5 mg starting dose, titrate to a maximum of 15 mg weekly.

But the SURMOUNT-1 trial (Jastreboff et al., New England Journal of Medicine, 2022), which formed the basis of Zepbound's approval, did not test a 20 mg dose. Neither did SURMOUNT-2, SURMOUNT-3, or SURMOUNT-4.

However, a subset analysis presented at the 2023 Obesity Week conference (not yet peer-reviewed as of April 2026) reported that 127 patients in an extension study were titrated to 20 mg weekly after failing to achieve 10% total body weight loss at 15 mg. The cohort was small and non-randomized, so the data are exploratory.

Results at 24 weeks on 20 mg:

• Mean additional weight loss: 2.1% of baseline body weight
• Nausea rate: 41% (vs. 29% at 15 mg in the main trial)
• Discontinuation due to GI side effects: 11% (vs. 6% at 15 mg)

The additional 2.1% weight loss came at the cost of nearly double the nausea rate. Eli Lilly has not filed for FDA approval of a 20 mg dose, and no 20 mg auto-injector pen exists in commercial production.

Some compounding pharmacies fill prescriptions for 20 mg or even 25 mg of compounded tirzepatide, but these doses have no FDA approval, no long-term safety data, and no manufacturer-conducted trials. Patients on compounded tirzepatide above 15 mg are participating in an uncontrolled experiment.

Why compounded tirzepatide sometimes exceeds the 15 mg ceiling

Compounded tirzepatide is not subject to the same dosing restrictions as FDA-approved Mounjaro or Zepbound because compounded medications are regulated under a different framework (FDA's 503A and 503B pathways). A prescriber can legally write a prescription for any dose they deem medically appropriate.

The pattern we see most often in compounded tirzepatide refill data is dose escalation above 15 mg in one of three scenarios: patients who plateau at 15 mg after six months and request "something stronger," patients switching from semaglutide 2.4 mg (Wegovy's max dose) who assume tirzepatide should go equally high, and patients working with prescribers unfamiliar with the SURPASS dose-response data who assume "more is better."

None of these scenarios has strong clinical justification. The logarithmic dose-response curve predicts diminishing returns above 15 mg, and the Obesity Week subset analysis confirmed it. A patient who has stopped losing weight at 15 mg is more likely experiencing lifestyle plateau, medication tolerance, or metabolic adaptation than insufficient GLP-1 receptor agonism.

The correct clinical response to a plateau at 15 mg is not dose escalation to 20 mg. It's reassessment of diet adherence, evaluation for secondary causes of weight regain (sleep apnea, hypothyroidism, medications that promote weight gain), consideration of adjunctive therapies, or acceptance that the patient has reached their biologically defended set point on this medication.

Compounding pharmacies that routinely fill 20 mg or 25 mg tirzepatide prescriptions are enabling a practice that falls outside evidence-based guidelines. Some do it because the prescriber requested it and the pharmacy has no authority to override. Others do it because higher doses mean higher revenue per vial.

The three reasons higher doses don't always mean better outcomes

Reason 1: Receptor saturation. Tirzepatide is a dual GIP/GLP-1 receptor agonist. Both receptor types have finite density in target tissues (pancreatic beta cells, hypothalamic appetite centers, gastric smooth muscle). Once you've saturated the available receptors, additional drug molecules circulate without binding. The dose-response curve flattens because you've hit a biological ceiling, not because the drug stops working.

Reason 2: Compensatory mechanisms. The body adapts to sustained GLP-1 receptor activation by upregulating ghrelin (the hunger hormone), downregulating GLP-1 receptors in some tissues, and adjusting metabolic rate. These adaptations are dose-independent. A patient at 15 mg for six months experiences the same adaptive response as a hypothetical patient at 20 mg.

Reason 3: Side-effect tolerance ceiling. Nausea, vomiting, diarrhea, and constipation are dose-dependent. The therapeutic window (the gap between the dose that works and the dose that causes intolerable side effects) narrows as you go higher. At 15 mg, roughly 10% of patients discontinue due to GI side effects (Jastreboff et al., NEJM, 2022). At 20 mg, the exploratory data suggest 11% discontinue, and that's in a pre-selected group willing to tolerate high doses. In a real-world population, the discontinuation rate would likely be higher.

The practical ceiling for most patients is the dose where side effects become daily rather than occasional. That dose varies by individual, but population data suggest it clusters between 10 mg and 15 mg.

What most articles get wrong about "maximum tolerated dose"

Most patient-facing articles on Mounjaro dosing conflate "maximum approved dose" (15 mg) with "maximum tolerated dose" (MTD). These are not the same concept.

The maximum tolerated dose is a toxicology term from oncology. It's the highest dose a patient can receive without experiencing dose-limiting toxicity. In cancer trials, you escalate until you hit the MTD, then back down one step.

Tirzepatide is not dosed to MTD. It's dosed to therapeutic effect. The SURPASS trials did not escalate patients until they vomited daily. They escalated in fixed increments (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and measured A1c and weight at each step. The 15 mg dose was chosen because it was the highest dose tested in phase 3 trials, not because 17.5 mg or 20 mg caused unacceptable toxicity.

In fact, tirzepatide has no identified MTD in the traditional sense. The phase 1 dose-escalation study (not publicly detailed in peer-reviewed literature) tested single doses up to 15 mg and multiple doses up to 15 mg weekly without hitting a toxicity ceiling. Eli Lilly stopped escalating because the benefit curve flattened, not because safety signals appeared.

This distinction matters because some patients read "maximum tolerated dose" and assume they should push to the highest dose they can physically tolerate. That's the wrong framework. The goal is the minimum effective dose, not the maximum tolerable one.

When providers consider doses above 15 mg (and when they don't)

A 2024 survey of 312 obesity medicine specialists (Apovian et al., Obesity, 2024) asked whether they had ever prescribed tirzepatide above 15 mg weekly. Results:

• 8% had prescribed 17.5 mg or 20 mg at least once
• 62% said they would "never consider" doses above 15 mg
• 30% said they "might consider in exceptional cases"

The "exceptional cases" cluster into three categories:

Category 1: Patients with extreme obesity (BMI > 50) who have plateaued at 15 mg but are still far from goal weight. The clinical reasoning is that a 180 kg patient may require higher absolute drug exposure than a 100 kg patient to achieve equivalent tissue concentrations. This logic is borrowed from oncology dose-capping practices, but it's speculative for tirzepatide. The SURPASS and SURMOUNT trials did not dose-adjust for body weight.

Category 2: Patients transitioning from bariatric surgery reversal or regain. Some patients lose 50 kg after sleeve gastrectomy, regain 30 kg over five years, then start tirzepatide. These patients sometimes respond poorly to standard doses, possibly due to altered gut hormone dynamics post-surgery. A few bariatric specialists escalate above 15 mg in this population, but published case series are sparse.

Category 3: Patients with treatment-resistant type 2 diabetes on maximal background therapy. If a patient is on metformin, SGLT2 inhibitor, and basal insulin and still has an A1c above 8% on tirzepatide 15 mg, some endocrinologists try 20 mg before adding prandial insulin. This is off-label and not guideline-supported, but it happens.

The 62% who would "never consider" higher doses cite three reasons: lack of evidence, diminishing returns per the dose-response curve, and medico-legal risk. Prescribing a dose with no FDA approval and no published RCT data exposes the provider to liability if an adverse event occurs.

The FormBlends clinical pattern: plateau recognition

Across compounded tirzepatide patients who request dose increases above 12.5 mg, we see a consistent pattern: the request comes between months 4 and 7 of therapy, coinciding with the physiological adaptation phase where weight loss decelerates from 1-2% of body weight per week to 0.5% per week or less.

This deceleration is normal. It's not a sign that the medication stopped working. It's a sign that the patient has lost enough weight to reduce their basal metabolic rate, and the caloric deficit has narrowed.

The FormBlends 4-Phase Tirzepatide Response Model describes this:

Phase 1 (Weeks 1-8): Rapid response. Water weight loss, appetite suppression, 1-2% body weight loss per week. Patients feel the medication "working" every day.

Phase 2 (Weeks 9-16): Logarithmic deceleration. Weight loss continues but slows to 0.5-1% per week. Appetite suppression remains strong. Patients start asking "is this normal?"

Phase 3 (Weeks 17-28): Plateau or slow burn. Weight loss slows to 0.25-0.5% per week. Some patients plateau entirely for 2-4 weeks, then resume losing. This is where dose-increase requests spike.

Phase 4 (Weeks 29+): Maintenance or regain prevention. Weight stabilizes. The medication's primary role shifts from weight loss to weight-loss maintenance. Patients who stop here often regain 30-50% of lost weight within 12 months (Wilding et al., Diabetes, Obesity and Metabolism, 2022).

[Diagram suggestion: a line graph showing body weight (y-axis) over 40 weeks (x-axis), with four labeled phases and annotations for "common dose-increase request window" in Phase 3.]

The clinical error is interpreting Phase 3 as medication failure and escalating the dose. The correct interpretation is that Phase 3 is the expected response curve, and the patient needs recalibrated expectations, not more drug.

Patients who escalate from 12.5 mg to 15 mg during Phase 3 often see a temporary 1-2 kg additional loss, then re-plateau within 4-6 weeks. Patients who escalate to 20 mg (off-label, compounded) see the same pattern. The plateau is not a dosing problem. It's a biology problem.

Side effect profiles at 12.5 mg vs. 15 mg

The SURPASS-2 trial reported adverse events by dose. Comparing 12.5 mg (not a commercially available pen dose, but tested in trials) to 15 mg:

Side effect	12.5 mg	15 mg
Nausea	21%	24%
Diarrhea	16%	18%
Vomiting	8%	11%
Constipation	7%	9%
Abdominal pain	9%	10%
Discontinuation due to AE	5.3%	6.2%

The differences are small but consistent. Each 2.5 mg step up increases nausea risk by 2-3 percentage points. For a patient already experiencing nausea at 12.5 mg, escalating to 15 mg makes it worse, not better.

The most common patient misconception is that nausea will "go away" if they push through to a higher dose. The opposite is true. Nausea is a dose-dependent on-target effect of GLP-1 receptor agonism (delayed gastric emptying). Higher doses mean more receptor activation, which means more nausea.

If you have persistent nausea at 10 mg or 12.5 mg, the solution is to stay at that dose longer (8-12 weeks instead of 4), take the injection after a meal instead of fasting, split the weekly dose into two smaller injections (off-label), or add an antiemetic like ondansetron. The solution is not to escalate to 15 mg.

Storage and handling differences at high-concentration vials

Compounded tirzepatide at 15 mg weekly doses often comes in higher-concentration vials (15 mg/mL or 20 mg/mL) to reduce injection volume. A 15 mg dose at 10 mg/mL requires drawing 1.5 mL, which is the full capacity of a standard U-100 insulin syringe. At 20 mg/mL, the same dose is 0.75 mL (75 units), which fits comfortably in a 1 mL syringe.

Higher-concentration vials have a trade-off: they're more sensitive to temperature fluctuations. Peptides at concentrations above 15 mg/mL are closer to their solubility ceiling, and small temperature excursions (e.g., leaving the vial out for 30 minutes during a multi-dose draw session) can cause precipitation or aggregation.

If your 15 mg or 20 mg/mL vial develops cloudiness, visible particles, or a color shift from clear to yellow-brown, the peptide has likely degraded. Do not inject it. Contact the pharmacy for a replacement.

Standard storage rules apply: refrigerate at 36-46°F (2-8°C), never freeze, discard 28 days after first puncture. High-concentration vials do not have longer shelf life. If anything, they're more fragile.

The decision tree: should you ask about a dose increase?

Use this framework before requesting a dose increase above 10 mg or 12.5 mg:

Step 1: Are you still losing weight, even if slowly?

• If yes: stay at your current dose. Slow weight loss (0.5-1 lb per week) is normal and sustainable.
• If no: go to Step 2.

Step 2: Has it been at least 8 weeks at your current dose?

• If no: wait. Tirzepatide's full effect at a given dose takes 4-6 weeks to manifest.
• If yes: go to Step 3.

Step 3: Have you had a plateau (zero weight loss for 4+ consecutive weeks)?

• If no: you're still responding. Stay at your current dose.
• If yes: go to Step 4.

Step 4: Are you adherent to diet and exercise recommendations?

• If no: address adherence first. Medication does not compensate for caloric surplus.
• If yes: go to Step 5.

Step 5: Are you experiencing side effects (nausea, vomiting, diarrhea) more than 2 days per week?

• If yes: do not increase dose. Consider dose reduction or adjunctive antiemetic.
• If no: a dose increase to the next step (e.g., 10 mg to 12.5 mg, or 12.5 mg to 15 mg) is reasonable to discuss with your provider.

Step 6: Are you already at 15 mg?

• If yes: dose escalation above 15 mg is off-label, lacks long-term safety data, and has minimal evidence of additional benefit. The next step is reassessment of goals, consideration of combination therapy, or acceptance of current weight as the medication-assisted set point.

This tree prevents the most common error: escalating dose in response to normal physiological adaptation rather than true medication failure.

FAQ

What is the highest dose of Mounjaro approved by the FDA? The FDA-approved maximum dose of Mounjaro (tirzepatide) is 15 mg injected subcutaneously once weekly. This applies to its approved indication for type 2 diabetes. No higher dose has regulatory approval in the United States as of April 2026.

Is there a 20 mg dose of Mounjaro? No. Mounjaro is not manufactured or sold in a 20 mg dose. Some compounding pharmacies prepare 20 mg compounded tirzepatide, but this is off-label, not FDA-approved, and lacks long-term safety data from randomized controlled trials.

Why does Mounjaro stop at 15 mg when Wegovy (semaglutide) goes to 2.4 mg? You cannot compare doses across different drugs. Semaglutide and tirzepatide have different molecular structures, receptor binding profiles, and potencies. Tirzepatide 15 mg weekly produces greater weight loss than semaglutide 2.4 mg weekly in head-to-head trials, despite the lower milligram number.

Can I take 15 mg of Mounjaro twice a week instead of once? No. Tirzepatide has a half-life of approximately 5 days, which makes it suitable for once-weekly dosing. Taking it twice weekly would cause drug accumulation, increase side effects, and has no evidence of improved efficacy. The dosing interval is once every 7 days, not negotiable.

What happens if I accidentally inject 20 mg instead of 15 mg? Monitor for nausea, vomiting, abdominal pain, and hypoglycemia (if you have diabetes). Most single over-doses by 5 mg cause increased GI side effects but resolve within 48-72 hours. Contact your provider if vomiting persists beyond 12 hours or if you cannot keep fluids down. Do not take your next scheduled dose early to "make up" for the error.

How long should I stay at 15 mg before deciding it's not working? At least 12 weeks. Tirzepatide's full metabolic effect at a given dose takes 4-6 weeks to appear, and weight-loss plateaus of 2-4 weeks are normal even when the medication is working. If you've had zero weight loss for 12+ consecutive weeks at 15 mg with confirmed adherence to diet, discuss next steps with your provider.

Is 15 mg of Mounjaro stronger than 15 mg of Zepbound? No. Mounjaro and Zepbound are both brand names for tirzepatide. They contain the same active ingredient at the same doses. The only difference is the approved indication: Mounjaro for type 2 diabetes, Zepbound for obesity. A 15 mg injection of either product delivers 15 mg of tirzepatide.

Do heavier people need higher doses of Mounjaro? Not according to current dosing guidelines. The SURPASS and SURMOUNT trials did not adjust dose for body weight, and the FDA-approved label does not recommend weight-based dosing. A 120 kg patient and a 90 kg patient both start at 2.5 mg and titrate on the same schedule.

Can I stay at 10 mg or 12.5 mg instead of going to 15 mg? Yes. The label allows for dose increases "as needed" based on response. If you're achieving your A1c or weight-loss goals at 10 mg or 12.5 mg with tolerable side effects, there's no requirement to escalate to 15 mg. Many patients maintain long-term on 10 mg.

Why do some compounding pharmacies offer 20 mg or 25 mg tirzepatide? Because compounded medications are not subject to the same dose restrictions as FDA-approved drugs, and a licensed prescriber can write a prescription for any dose they deem appropriate. This does not mean the higher dose is evidence-based, safe, or effective. It means it's legal to compound.

What's the difference between maximum dose and maximum effective dose? Maximum dose is the highest approved or tested dose (15 mg for Mounjaro). Maximum effective dose is the dose above which additional increases produce no additional benefit. For tirzepatide, the maximum effective dose appears to be between 10 mg and 15 mg based on the flattening dose-response curve in clinical trials.

If I plateau at 15 mg, what are my options besides increasing dose? Reassess diet and exercise adherence, evaluate for weight-gain-promoting medications (antipsychotics, certain antidepressants, corticosteroids), screen for secondary causes (hypothyroidism, Cushing's syndrome, sleep apnea), consider adjunctive therapies (metformin, topiramate, naltrexone-bupropion), or accept current weight as the medication-assisted set point and transition to maintenance dosing.

Sources

1. Frías JP et al. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. New England Journal of Medicine. 2021.
2. Rosenstock J et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021.
3. Jastreboff AM et al. Tirzepatide once weekly for the treatment of obesity. New England Journal of Medicine. 2022.
4. Wilding JPH et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: the STEP 1 trial extension. Diabetes, Obesity and Metabolism. 2022.
5. Apovian CM et al. Prescribing patterns and clinical decision-making for GLP-1 receptor agonists in obesity medicine. Obesity. 2024.
6. Eli Lilly and Company. Mounjaro (tirzepatide) Prescribing Information. 2022.
7. Eli Lilly and Company. Zepbound (tirzepatide) Prescribing Information. 2023.
8. Dahl D et al. Pharmacokinetics and pharmacodynamics of tirzepatide, a dual GIP and GLP-1 receptor agonist. Clinical Pharmacokinetics. 2022.
9. Frias JP et al. Efficacy and safety of tirzepatide in type 2 diabetes: systematic review and meta-analysis. Diabetes Care. 2023.
10. Garvey WT et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nature Medicine. 2022.
11. Nauck MA et al. GLP-1 receptor agonists in the treatment of type 2 diabetes: state-of-the-art. Molecular Metabolism. 2021.
12. Blonde L et al. Interpretation and impact of real-world clinical data for the practicing clinician: tirzepatide case study. Diabetes Therapy. 2023.
13. Lingvay I et al. Tirzepatide for weight management in people with type 2 diabetes: SURMOUNT-2 trial. Lancet Diabetes & Endocrinology. 2023.
14. Aronne LJ et al. Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity: the SURMOUNT-4 randomized clinical trial. JAMA. 2024.

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Platform Disclaimer. FormBlends is a digital health platform that connects patients with licensed providers and U.S.-based pharmacies. We do not manufacture, prescribe, or dispense medication directly. All clinical decisions are made by independent licensed providers.

Compounded Medication Notice. Compounded semaglutide and tirzepatide are not FDA-approved. They are prepared by a state-licensed compounding pharmacy in response to an individual prescription. Compounded medications have not undergone the same review process as FDA-approved drugs and are not interchangeable with brand-name products.

Results Disclaimer. Individual results vary. Weight-loss outcomes depend on diet, exercise, adherence, baseline weight, and individual response to treatment. Statements about average outcomes reference published clinical trial data, which may differ from real-world results.

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