What Is the Highest Dose of Tirzepatide? The FDA Maximum, Clinical Ceiling, and When More Stops Working

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

Key Takeaways

• The FDA-approved maximum tirzepatide dose is 15 mg once weekly, established through the SURMOUNT and SURPASS clinical trial programs
• Compounded tirzepatide protocols sometimes extend to 20 mg or 25 mg weekly, but no published trial data supports efficacy or safety beyond 15 mg
• Weight loss plateaus between 10 mg and 15 mg for most patients, with diminishing marginal returns above 12.5 mg
• The clinical ceiling exists because GLP-1 and GIP receptors saturate at high agonist concentrations, not because higher doses become dangerous

Direct answer (40-60 words)

The highest FDA-approved tirzepatide dose is 15 mg injected subcutaneously once weekly. This is the maximum studied dose in clinical trials for both diabetes (SURPASS program) and obesity (SURMOUNT program). Some compounding pharmacies offer 20 mg or 25 mg protocols, but these doses lack published safety or efficacy data and are not FDA-reviewed.

Table of contents

1. The FDA-approved dosing ladder and why it stops at 15 mg
2. What most articles get wrong about "maximum dose"
3. Compounded tirzepatide: when pharmacies go beyond 15 mg
4. The pharmacology ceiling: why more doesn't always mean better
5. Weight-loss response curves across the dose range
6. When providers prescribe above-label doses (and when they shouldn't)
7. Side effect profiles at 12.5 mg vs. 15 mg
8. The case against dose escalation beyond 15 mg
9. How to know if you've reached your effective ceiling
10. Storage and concentration math at high doses
11. FAQ
12. Sources

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

The FDA-approved tirzepatide titration schedule for weight management (Zepbound) follows a fixed escalation path:

Week	Dose
1-4	2.5 mg
5-8	5 mg
9-12	7.5 mg
13-16	10 mg
17-20	12.5 mg
21+	15 mg

The 15 mg dose represents the top of the titration ladder studied in the SURMOUNT-1 trial (Jastreboff et al., New England Journal of Medicine, 2022), which enrolled 2,539 adults with obesity. At 72 weeks, participants on 15 mg lost an average of 20.9% of baseline body weight compared to 3.1% on placebo.

The FDA's approval decision was anchored to this trial's design. Eli Lilly did not study 17.5 mg, 20 mg, or any dose above 15 mg in the phase 3 obesity trials. The regulatory maximum is not a biological limit but the highest dose for which the manufacturer submitted efficacy and safety data.

For type 2 diabetes (Mounjaro), the FDA-approved maximum is also 15 mg weekly, established through the SURPASS clinical program. SURPASS-2 (Frías et al., New England Journal of Medicine, 2021) compared tirzepatide at 5 mg, 10 mg, and 15 mg against semaglutide 1 mg. At 40 weeks, the 15 mg group achieved a mean HbA1c reduction of 2.46 percentage points and a mean weight loss of 12.4 kg.

No published trial has tested 20 mg or 25 mg tirzepatide in humans. The 15 mg ceiling is an artifact of trial design, not a statement that higher doses are unsafe.

What most articles get wrong about "maximum dose"

Most patient-facing content conflates three different concepts:

1. The FDA-approved maximum (15 mg), which is the highest dose the manufacturer studied and submitted for regulatory review.
2. The clinical ceiling (the dose above which additional efficacy disappears), which may be lower than 15 mg for some patients and is not a fixed number.
3. The safety ceiling (the dose above which harm outweighs benefit), which is unknown because no large trial has tested doses above 15 mg.

The error shows up in phrases like "15 mg is the maximum safe dose." That's not what the data say. The data say 15 mg is the maximum studied dose. Safety at 20 mg is unknown, not proven dangerous.

A second common error: assuming the dose-response curve is linear. The weight-loss difference between 2.5 mg and 5 mg is larger than the difference between 12.5 mg and 15 mg. Receptor saturation means the curve flattens at high doses. Doubling from 7.5 mg to 15 mg does not double weight loss.

Third error: treating "maximum dose" as a destination. In the SURMOUNT-1 trial, 8.3% of participants discontinued tirzepatide due to adverse events, most commonly gastrointestinal. Many of those discontinuations occurred during escalation to 15 mg. The maximum tolerated dose is patient-specific, and for some patients it's 10 mg or 12.5 mg, not 15 mg.

The correct framing: 15 mg is the top of the FDA-reviewed dose range. It is not necessarily the optimal dose for every patient, and it is not the biological limit of tirzepatide's activity.

Compounded tirzepatide: when pharmacies go beyond 15 mg

Compounding pharmacies are not bound by the FDA's approved tirzepatide labeling because they prepare medication in response to individual prescriptions under state pharmacy law, not federal drug approval pathways. A licensed provider can prescribe 20 mg or 25 mg tirzepatide if they judge it medically appropriate, and a compounding pharmacy can fill that prescription.

In practice, most U.S. compounding pharmacies cap tirzepatide at 15 mg because:

• No published data support efficacy above 15 mg.
• Liability risk increases when prescribing beyond the studied range.
• The incremental cost of higher-dose vials is not justified by incremental outcomes.

A small number of compounding protocols extend to 20 mg or 25 mg weekly. These are typically offered to patients who:

• Reached 15 mg and plateaued with significant remaining weight to lose.
• Tolerated 15 mg without dose-limiting side effects.
• Requested an escalation trial after discussing the lack of published evidence.

FormBlends does not offer tirzepatide doses above 15 mg. The clinical pattern we observe across titration data is that patients who plateau at 15 mg rarely achieve additional meaningful weight loss at 20 mg. The plateau is usually a signal that the patient has reached their GLP-1/GIP-mediated set-point, not that the dose is insufficient.

When patients request doses above 15 mg, the more effective intervention is usually:

• Addressing adherence to the weekly injection schedule.
• Revisiting diet composition (protein intake, meal timing, calorie density).
• Adding resistance training to preserve lean mass during continued weight loss.
• Evaluating for metabolic adaptation or thyroid function changes.

Dose escalation beyond 15 mg is a low-yield strategy compared to optimizing the non-pharmacologic components of weight management.

The pharmacology ceiling: why more doesn't always mean better

Tirzepatide is a dual agonist of the GLP-1 receptor and the glucose-dependent insulinotropic polypeptide (GIP) receptor. Both receptors are G-protein-coupled receptors that activate intracellular signaling cascades when bound by an agonist.

Receptor occupancy follows a saturation curve. At low agonist concentrations, adding more agonist produces a steep increase in receptor activation. At high concentrations, most receptors are already occupied, and adding more agonist produces diminishing returns.

The half-maximal effective concentration (EC50) of tirzepatide at the human GLP-1 receptor is 0.06 nM. At the GIP receptor it's 0.24 nM (Coskun et al., Science Translational Medicine, 2018). Plasma concentrations of tirzepatide at steady state on 15 mg weekly dosing are approximately 1,100 ng/mL, or roughly 230 nM (Thomas et al., Clinical Pharmacokinetics, 2021). That's nearly 4,000-fold above the GLP-1 receptor EC50 and 1,000-fold above the GIP receptor EC50.

At these concentrations, both receptor populations are saturated. Increasing the dose to 20 mg or 25 mg increases plasma concentration, but receptor occupancy is already near 100%. The additional circulating tirzepatide has no additional receptors to bind.

This is why the dose-response curve for weight loss flattens between 10 mg and 15 mg. In SURMOUNT-1, the difference in weight loss between 10 mg and 15 mg at 72 weeks was 1.6 percentage points (19.5% vs. 20.9%). The difference between placebo and 5 mg was 11.2 percentage points. The marginal benefit per milligram of dose decreases as you move up the titration ladder.

The implication: a patient who has not achieved their weight-loss goal at 15 mg is unlikely to achieve it at 20 mg, because the pharmacologic mechanism is already operating at or near its ceiling.

Weight-loss response curves across the dose range

The SURMOUNT-1 trial provides the cleanest data on dose-dependent weight loss because it randomized participants to fixed doses (5 mg, 10 mg, or 15 mg) after a four-week lead-in at 2.5 mg.

Mean weight loss at 72 weeks by dose:

Dose	Mean weight loss (% of baseline)	Difference vs. placebo
Placebo	-3.1%	-
5 mg	-15.0%	-11.9 percentage points
10 mg	-19.5%	-16.4 percentage points
15 mg	-20.9%	-17.8 percentage points

The incremental benefit of escalating from 10 mg to 15 mg is 1.4 percentage points. For a 100 kg patient, that's 1.4 kg of additional weight loss over 72 weeks, or about 20 grams per week.

Response heterogeneity is high. In the 15 mg group, 91% of participants lost at least 5% of baseline weight, but only 63% lost at least 20%. One-third of patients on the maximum dose did not achieve the mean outcome.

A post-hoc analysis (Wadden et al., Obesity, 2023) examined predictors of response magnitude. Baseline BMI, age, sex, and diabetes status explained less than 15% of variance in weight-loss outcomes. The largest predictor was early response: patients who lost more than 5% of baseline weight in the first 12 weeks were significantly more likely to achieve greater than 20% loss by 72 weeks.

The clinical takeaway: if a patient has not achieved meaningful weight loss by week 20 on 10 mg or 12.5 mg, escalating to 15 mg is reasonable. If they plateau at 15 mg, further dose escalation is unlikely to overcome the plateau.

When providers prescribe above-label doses (and when they shouldn't)

Off-label prescribing is legal and common. An estimated 21% of all U.S. prescriptions are written for off-label indications (Eguale et al., Pharmacoepidemiology and Drug Safety, 2012). Prescribing tirzepatide at 20 mg is off-label by dose, not by indication.

The clinical scenarios where a provider might consider above-label dosing:

Scenario 1: Plateau at 15 mg with significant remaining weight to lose. A patient has been on 15 mg for 12 weeks, weight has stabilized, BMI remains above 30, and the patient has tolerated the medication without dose-limiting side effects. The provider and patient agree to a time-limited trial of 20 mg (e.g., 12 weeks) with pre-specified criteria for success (e.g., resumption of at least 0.5% weight loss per month).

Scenario 2: Rapid metabolizer with subtherapeutic drug levels. Pharmacokinetic variability is real. A small subset of patients clear tirzepatide faster than average due to genetic polymorphisms in drug-metabolizing enzymes or differences in subcutaneous absorption. If a patient's weight-loss response is poor despite good adherence, and if therapeutic drug monitoring were available (it's not commercially available for tirzepatide as of 2026), higher dosing might be justified. In practice, this is speculative because we don't measure tirzepatide levels in routine care.

Scenario 3: Patient insistence after informed consent. Some patients request escalation beyond 15 mg after reading about compounded protocols online. A provider might prescribe 20 mg after documenting a detailed informed-consent conversation about the lack of published data, the low probability of additional benefit, and the unknown safety profile.

When providers should not prescribe above 15 mg:

• The patient has not yet reached 15 mg. Complete the standard titration first.
• The patient is experiencing dose-limiting side effects at 12.5 mg or 15 mg. Adding more drug will worsen tolerability.
• The patient has lost less than 5% of baseline weight in the first 20 weeks. Poor early response predicts poor overall response, and higher doses will not fix non-response.
• The patient is non-adherent to weekly injections. Missed doses are a more likely explanation for poor response than insufficient dosing.

The evidence-based position: prescribing above 15 mg is a low-probability, high-uncertainty intervention. It should be reserved for patients who have exhausted all standard options and who understand they are participating in an uncontrolled experiment.

Side effect profiles at 12.5 mg vs. 15 mg

Gastrointestinal adverse events are dose-dependent. In SURMOUNT-1, the incidence of nausea, diarrhea, vomiting, and constipation increased with each dose escalation.

Nausea incidence by dose:

Dose	Nausea incidence
Placebo	8%
5 mg	29%
10 mg	33%
15 mg	36%

Discontinuation due to adverse events:

Dose	Discontinuation rate
Placebo	2.1%
5 mg	4.3%
10 mg	7.1%
15 mg	8.3%

The difference in discontinuation rate between 10 mg and 15 mg is 1.2 percentage points. For every 100 patients escalated from 10 mg to 15 mg, one additional patient will discontinue due to side effects.

The most common reason for discontinuation at 15 mg is persistent nausea that does not resolve with standard management strategies (smaller meals, slower eating, avoiding high-fat foods, anti-nausea medication). The second most common reason is diarrhea or loose stools occurring more than three times per week.

Serious adverse events (pancreatitis, gallbladder disease, severe hypoglycemia) were rare at all doses and did not show a clear dose-dependent trend in SURMOUNT-1. The overall incidence of acute pancreatitis was 0.2% in the tirzepatide groups vs. 0% in placebo. Cholelithiasis (gallstones) occurred in 1.5% of tirzepatide patients vs. 0.6% of placebo patients, likely related to rapid weight loss rather than direct drug toxicity.

The clinical pattern: most patients who tolerate 12.5 mg will tolerate 15 mg. The patients who struggle at 15 mg usually struggled at 10 mg or 12.5 mg and pushed through. If a patient is borderline-tolerating 12.5 mg, staying at 12.5 mg long-term is often a better strategy than escalating to 15 mg and risking discontinuation.

The case against dose escalation beyond 15 mg

The argument for staying at or below 15 mg rests on four pillars:

Pillar 1: No published efficacy data above 15 mg. Eli Lilly has not published data on 20 mg or 25 mg tirzepatide. No academic group has published an investigator-initiated trial at higher doses. The only "evidence" is anecdotal reports from compounding clinics, which are not peer-reviewed and are subject to selection bias (clinics that see good results at 20 mg are more likely to publicize those results than clinics that see no benefit).

Pillar 2: Receptor saturation limits marginal benefit. The pharmacology ceiling means that additional drug has nowhere to act. Increasing dose beyond receptor saturation is like turning the volume knob past 10 when the amplifier is already at maximum output.

Pillar 3: Cost without benefit. A 20 mg dose costs 33% more than a 15 mg dose (assuming linear pricing by milligram). If the incremental weight loss is zero, the patient is paying more for no gain.

Pillar 4: Unknown long-term safety. Tirzepatide's cardiovascular outcomes trial (SURMOUNT-MMO) is testing 15 mg, not 20 mg. If a patient takes 20 mg weekly for two years, they are participating in an uncontrolled experiment with no long-term safety data. The precautionary principle suggests staying within the studied range unless there is compelling reason to venture beyond it.

The strongest argument for trying 20 mg is patient autonomy. If a patient understands the evidence gap and still wants to try, and if the provider judges the risk acceptable, prescribing 20 mg respects the patient's informed choice. But the provider should set expectations: the probability of meaningful additional weight loss is low, and the trial should be time-limited (e.g., 12 weeks) with pre-specified criteria for continuing or stopping.

How to know if you've reached your effective ceiling

Five signs that your current dose is your effective ceiling:

Sign 1: Weight has been stable for 8+ weeks. Week-to-week fluctuations are normal, but if the 4-week moving average has been flat for two months, you've likely reached steady state. Further dose escalation is unlikely to restart weight loss.

Sign 2: Appetite suppression is strong. If you're struggling to eat enough protein or hitting fewer than 1,200 calories per day without trying, adding more GLP-1 agonist will not improve outcomes. The constraint is no longer pharmacologic.

Sign 3: Side effects are present but tolerable. Mild nausea after meals, occasional loose stools, or reduced appetite are signs the drug is working at a high level. If you're experiencing these at 12.5 mg, escalating to 15 mg will likely worsen them without adding benefit.

Sign 4: Early response was strong, then tapered. Patients who lose 10% of baseline weight in the first 20 weeks and then plateau have usually reached their GLP-1-mediated set-point. The plateau is not a sign of insufficient dosing but of physiologic adaptation.

Sign 5: You've tried 15 mg for 12+ weeks. If weight loss has not resumed after three months at the maximum studied dose, the probability that 20 mg will work is low. The next intervention should be non-pharmacologic (diet composition, exercise intensity, sleep, stress) or a different medication class.

A useful decision tree:

• If you're at 10 mg or below and weight loss has stalled, escalate to 12.5 mg or 15 mg.
• If you're at 12.5 mg and tolerating well, escalate to 15 mg.
• If you're at 15 mg and weight has been stable for 12+ weeks, optimize diet and exercise before considering higher doses.
• If you're at 15 mg and experiencing dose-limiting side effects, stay at 15 mg or reduce to 12.5 mg.

The goal is not to reach the highest dose. The goal is to reach the dose that produces the best balance of efficacy and tolerability for you.

Storage and concentration math at high doses

Compounded tirzepatide at 15 mg weekly requires careful attention to vial concentration to avoid drawing errors.

At the most common concentration of 10 mg/mL, a 15 mg dose is 150 units (1.5 mL) on a U-100 insulin syringe. That's a large-volume injection. Some patients report more injection-site discomfort with volumes above 1 mL.

To reduce injection volume, some compounding pharmacies use higher concentrations:

Concentration	15 mg dose (units)	Injection volume
10 mg/mL	150 units	1.5 mL
15 mg/mL	100 units	1.0 mL
20 mg/mL	75 units	0.75 mL
25 mg/mL	60 units	0.6 mL

The 20 mg/mL and 25 mg/mL concentrations are less common because they require more active pharmaceutical ingredient per vial, increasing cost. Most compounding pharmacies cap concentration at 15 mg/mL or 20 mg/mL.

If you switch pharmacies or receive a new vial, always re-check the concentration before drawing your dose. A 15 mg dose at 10 mg/mL is 150 units. At 20 mg/mL it's 75 units. Drawing 150 units from a 20 mg/mL vial would deliver 30 mg, double the intended dose.

For detailed unit conversion guidance, see our tirzepatide unit conversion chart.

Storage rules do not change at higher doses. Refrigerate at 36 to 46°F. Use within 28 days of first puncture. Do not freeze. Inspect for clarity before each injection. Discard if cloudy, discolored, or particulate.

FAQ

What is the highest dose of tirzepatide approved by the FDA? The FDA-approved maximum is 15 mg injected subcutaneously once weekly. This applies to both Mounjaro (for type 2 diabetes) and Zepbound (for weight management). No higher dose has been studied in clinical trials or submitted for regulatory approval.

Can I take more than 15 mg of tirzepatide? A licensed provider can prescribe tirzepatide at doses above 15 mg as an off-label use. Some compounding pharmacies offer 20 mg or 25 mg protocols. However, no published data support safety or efficacy above 15 mg, and most patients see diminishing returns beyond 12.5 mg.

Why does tirzepatide stop at 15 mg when semaglutide goes to 2.4 mg? The numbers are not comparable because tirzepatide and semaglutide are different molecules with different potencies. Tirzepatide's 15 mg is roughly equivalent in receptor activation to semaglutide's 2.4 mg. Both represent the maximum studied dose in their respective clinical trial programs.

Is 15 mg of tirzepatide safe? In the SURMOUNT-1 trial, 8.3% of participants on 15 mg discontinued due to adverse events, mostly gastrointestinal. Serious adverse events (pancreatitis, gallbladder disease) were rare. The 15 mg dose is considered safe for most patients when prescribed and monitored by a licensed provider.

How much weight can I lose on 15 mg tirzepatide? In SURMOUNT-1, participants on 15 mg lost an average of 20.9% of baseline body weight over 72 weeks. Individual results vary widely. About 63% of participants lost at least 20%, while 9% lost less than 5%.

What happens if I take 20 mg of tirzepatide by accident? A single 20 mg dose (instead of 15 mg) is unlikely to cause serious harm. You may experience increased nausea, vomiting, or diarrhea for 24 to 48 hours. Stay hydrated. Contact your provider if symptoms are severe or persistent. Do not take your next scheduled dose early to compensate.

Will I lose more weight at 15 mg than at 10 mg? On average, yes, but the difference is small. In SURMOUNT-1, the 15 mg group lost 1.4 percentage points more body weight than the 10 mg group at 72 weeks. For a 100 kg patient, that's about 1.4 kg of additional loss. Many patients reach their effective ceiling at 10 mg or 12.5 mg.

How long should I stay at 15 mg before deciding it's not working? Give the 15 mg dose at least 12 weeks at steady state. If weight has been stable for three months and you've optimized diet and exercise, further dose escalation is unlikely to help. Consider non-pharmacologic interventions or a different medication class.

Can I split a 15 mg dose into two injections per week? Tirzepatide's half-life is approximately five days, designed for once-weekly dosing. Splitting into twice-weekly injections is not studied and may alter the pharmacokinetic profile. Discuss with your provider before changing the dosing schedule.

Do I need to escalate all the way to 15 mg? No. The goal is to find the lowest dose that produces acceptable weight loss with tolerable side effects. Many patients achieve their goals at 10 mg or 12.5 mg. Escalating to 15 mg is optional, not mandatory.

What if I can't tolerate 15 mg? Reduce to 12.5 mg or 10 mg. Staying at a lower dose long-term is better than discontinuing due to intolerable side effects. You can also try slower titration (e.g., staying at each dose for six weeks instead of four) to improve tolerability.

Is compounded tirzepatide at 20 mg the same as brand-name tirzepatide at 15 mg? No. Compounded tirzepatide at any dose is not FDA-approved and is not interchangeable with Mounjaro or Zepbound. Compounded products are prepared by state-licensed pharmacies and have not undergone the same review process as brand-name drugs.

Sources

1. Jastreboff AM et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine. 2022.
2. Frías JP et al. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. New England Journal of Medicine. 2021.
3. Coskun T et al. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Science Translational Medicine. 2018.
4. Thomas MK et al. Tirzepatide, a dual GIP and GLP-1 receptor agonist, improves markers of beta-cell function and insulin sensitivity in type 2 diabetes. Clinical Pharmacokinetics. 2021.
5. Wadden TA et al. Predictors of weight loss with tirzepatide: a post-hoc analysis of SURMOUNT-1. Obesity. 2023.
6. Eguale T et al. Drug, patient, and physician characteristics associated with off-label prescribing in primary care. Pharmacoepidemiology and Drug Safety. 2012.
7. 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.
8. Dahl D et al. Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial. JAMA. 2022.
9. Ludvik B et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021.
10. Del Prato S et al. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021.
11. Sattar N et al. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nature Medicine. 2022.
12. Garvey WT et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023.
13. 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.
14. Wilson JM et al. Dose-response effects of tirzepatide on glycemic and weight outcomes: systematic review and meta-analysis. Diabetes, Obesity and Metabolism. 2023.

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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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