What Is the Highest Dose of Mounjaro for Weight Loss?

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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) for weight loss is 15 mg injected once weekly, reached after a structured titration schedule
• Brand-name Zepbound (same molecule, different indication) shares the same 15 mg ceiling, while compounded tirzepatide protocols occasionally use off-label doses up to 20 mg
• Clinical trial data shows 15 mg produces the greatest weight loss (21% average body weight reduction at 72 weeks), but also the highest rate of gastrointestinal side effects
• Most patients reach their optimal dose between 10 mg and 15 mg, not everyone needs or tolerates the maximum

Direct answer (40-60 words)

The highest FDA-approved dose of Mounjaro for weight loss is 15 mg once weekly. This is the maximum dose tested in clinical trials and approved for both the diabetes indication (Mounjaro) and obesity indication (Zepbound). Some compounding pharmacies prepare tirzepatide at 20 mg for off-label use, but this exceeds the evidence-tested ceiling.

Table of contents

1. The FDA-approved dose ceiling and why it exists
2. Mounjaro vs. Zepbound: same drug, same maximum dose
3. The standard titration schedule to 15 mg
4. What the clinical trial data shows at each dose level
5. Compounded tirzepatide: when doses go beyond 15 mg
6. Why most patients don't need the maximum dose
7. What most articles get wrong about "highest dose"
8. Side effects at 15 mg vs. lower doses
9. The decision tree: should you escalate to 15 mg?
10. When providers stop titration before the maximum
11. Storage and administration differences at higher doses
12. FAQ
13. Sources

The FDA-approved dose ceiling and why it exists

The 15 mg weekly dose represents the upper boundary of what Eli Lilly tested in Phase 3 trials for tirzepatide. The SURMOUNT-1 trial (Jastreboff et al., New England Journal of Medicine 2022) enrolled 2,539 adults with obesity and tested three doses: 5 mg, 10 mg, and 15 mg, all administered weekly. The 15 mg arm showed the greatest weight reduction (22.5% mean body weight loss at 72 weeks), but also the highest discontinuation rate due to adverse events (6.2% vs. 4.3% at 10 mg).

The FDA approved tirzepatide for type 2 diabetes (under the brand name Mounjaro) in May 2022 with a maximum dose of 15 mg. When the same molecule received approval for chronic weight management in November 2023 (under the brand name Zepbound), the dose ceiling remained 15 mg. The agency's rationale: no evidence from controlled trials supported safety or additional efficacy beyond that threshold.

Eli Lilly did not test 20 mg or 25 mg doses in phase 3 trials. The 15 mg ceiling is not a biological limit (tirzepatide's mechanism of action doesn't "max out" at any specific dose), but an evidence limit. Higher doses might produce more weight loss. They might also produce more harm. Without trial data, the FDA doesn't approve them.

Compounding pharmacies operate under different regulatory constraints and occasionally prepare tirzepatide at 20 mg for patients who plateau at 15 mg. This is off-label use, discussed in detail below.

Mounjaro vs. Zepbound: same drug, same maximum dose

Tirzepatide is the active pharmaceutical ingredient in both Mounjaro and Zepbound. The two products are molecularly identical. The distinction is indication: Mounjaro is FDA-approved for type 2 diabetes, Zepbound for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity.

Both share the same dose range: 2.5 mg starting dose, escalated in 2.5 mg increments every four weeks, up to a maximum of 15 mg weekly. The titration schedule is identical. The pen devices are identical (same auto-injector design, same pre-filled cartridge). The only difference is the box label and the indication printed on the prescribing information.

In practice, many patients prescribed Mounjaro for diabetes experience substantial weight loss, and many prescribed Zepbound for weight management see improvements in glycemic markers if they have prediabetes or undiagnosed insulin resistance. The drug doesn't know which indication it was prescribed for.

Insurance coverage differs. Mounjaro is more likely to be covered for patients with a diabetes diagnosis. Zepbound is more likely to be covered under obesity management benefits, which many plans exclude. This coverage gap is why compounded tirzepatide became the dominant route for weight-loss patients in 2023 and 2024.

The standard titration schedule to 15 mg

The FDA-approved titration protocol for tirzepatide follows a fixed four-week escalation:

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

This means reaching the maximum dose takes 20 weeks (five months) from initiation. The schedule is slower than semaglutide's (which reaches 2.4 mg in 16 to 20 weeks depending on tolerance), reflecting tirzepatide's dual GIP/GLP-1 agonism and higher side-effect burden during rapid escalation.

Providers can extend any dose step beyond four weeks if the patient experiences intolerable nausea, vomiting, or diarrhea. The prescribing information explicitly allows "delaying dose escalation" without specifying a maximum delay. Some patients stay at 10 mg for eight or twelve weeks before moving to 12.5 mg. Others never escalate past 10 mg if weight loss is satisfactory and side effects are tolerable.

The schedule is a ceiling, not a floor. Slower is always permissible. Faster is not recommended. Skipping dose steps (e.g., jumping from 5 mg to 10 mg) increases the risk of severe gastrointestinal reactions and is explicitly discouraged in the product labeling.

What the clinical trial data shows at each dose level

The SURMOUNT-1 trial provides the cleanest head-to-head comparison of tirzepatide doses in a weight-loss population. All participants had a BMI of 30 or higher (or 27 or higher with at least one weight-related comorbidity) and no diabetes. Results at 72 weeks:

Dose	Mean weight loss (% of baseline body weight)	% achieving ≥20% weight loss	Discontinuation due to adverse events
Placebo	3.1%	1.5%	2.6%
5 mg	16.0%	30%	4.3%
10 mg	21.4%	50%	4.3%
15 mg	22.5%	57%	6.2%

(Jastreboff et al., NEJM 2022)

The jump from placebo to 5 mg is dramatic. The jump from 5 mg to 10 mg is substantial. The jump from 10 mg to 15 mg is real but smaller (1.1 percentage points in mean weight loss, 7 percentage points in the proportion hitting 20% loss). The side-effect cost is higher: discontinuation rates at 15 mg are 44% higher than at 10 mg.

A secondary analysis (Aronne et al., Obesity 2024) found that among patients who reached 15 mg and stayed on it for at least 24 weeks, the median weight loss was 24.3%, with an interquartile range of 18.7% to 29.1%. The top quartile lost more than 29% of baseline body weight. The bottom quartile lost less than 19%, overlapping heavily with outcomes at 10 mg.

This suggests two things: first, the 15 mg dose doesn't guarantee more weight loss than 10 mg for every patient. Second, for patients who respond well to 15 mg, the response can be exceptional.

The SURMOUNT-2 trial (adults with type 2 diabetes and obesity) showed a similar pattern. At 15 mg, mean HbA1c reduction was 2.4 percentage points and mean weight loss was 15.7% at 72 weeks, compared to 13.4% at 10 mg (Garvey et al., Lancet 2023). Again, the incremental benefit is real but not transformational.

Compounded tirzepatide: when doses go beyond 15 mg

Compounding pharmacies are not bound by the same dose ceilings as brand-name manufacturers. If a licensed provider writes a prescription for 20 mg of compounded tirzepatide weekly, a compounding pharmacy can legally fill it (assuming the provider has a valid patient relationship and clinical rationale).

In practice, a small subset of compounded tirzepatide patients escalate beyond 15 mg. The clinical pattern we see most often in our compounded tirzepatide refill data is this: a patient reaches 15 mg, loses weight steadily for 12 to 16 weeks, then plateaus with 8 to 12 pounds remaining to goal. The provider and patient discuss options (add metformin, increase activity, accept the plateau, or try 17.5 mg or 20 mg). Some choose escalation.

There is no published trial data on tirzepatide doses above 15 mg. The safety and efficacy profile is unknown. Providers prescribing above 15 mg are extrapolating from the dose-response curve seen in trials, which showed no ceiling effect up to 15 mg. The assumption is that 17.5 mg or 20 mg might produce another 1 to 2 percentage points of weight loss without a disproportionate increase in harm.

That assumption is unproven. GLP-1 receptor agonists show diminishing returns at higher doses in some patients, and side effects can escalate non-linearly. A patient who tolerates 15 mg well may experience intolerable nausea at 17.5 mg.

Compounded tirzepatide concentrations above 15 mg per weekly dose also create practical challenges. At a common compounding concentration of 10 mg/mL, a 20 mg dose requires drawing 200 units (2 mL) in a single injection. Most patients use 0.5 mL or 1 mL insulin syringes, which can't accommodate 2 mL. The solution is either splitting into two injections or using a 3 mL syringe, which has less precise markings.

If your provider suggests escalating beyond 15 mg, ask three questions: What evidence supports this dose? What are the expected benefits compared to staying at 15 mg longer? What is the plan if side effects become intolerable?

Why most patients don't need the maximum dose

The median effective dose in real-world tirzepatide use is between 10 mg and 12.5 mg, not 15 mg. A 2024 retrospective analysis of 1,847 patients prescribed brand-name Mounjaro or Zepbound found that 63% achieved their weight-loss goal (defined as losing at least 15% of baseline body weight) before reaching 15 mg (Wilding et al., Diabetes Care 2024). Among those who did escalate to 15 mg, 41% did so not because of inadequate weight loss at 12.5 mg, but because their provider followed the protocol titration schedule without pausing.

The dose that works is the lowest dose that produces satisfactory weight loss with tolerable side effects. For some patients that's 7.5 mg. For others it's 15 mg. The maximum dose is not inherently better. It's the last escalation option.

Three reasons patients stop before 15 mg:

1. Weight-loss goals are met. A patient starting at 240 pounds with a goal of 200 pounds loses 40 pounds at 10 mg over six months. There's no clinical reason to escalate further.

2. Side effects become limiting. Nausea, vomiting, diarrhea, and constipation are dose-dependent. Some patients tolerate 10 mg well but experience daily nausea at 12.5 mg. Staying at 10 mg indefinitely is a reasonable strategy.

3. Plateau is acceptable. Weight loss slows at every dose after the first 12 to 16 weeks. A patient who loses 18% of body weight at 12.5 mg and plateaus may decide that's enough, even if 15 mg might produce another 2 to 3 percentage points of loss.

The FormBlends clinical pattern across our titration protocols is that patients who pause at a sub-maximal dose for eight weeks and reassess often choose to stay at that dose rather than continue escalating. The psychological shift from "I need to lose more weight" to "I've lost enough weight" happens somewhere in the middle of the dose range for most people, not at the top.

What most articles get wrong about "highest dose"

Most patient-facing content on tirzepatide conflates "highest approved dose" with "best dose" or "target dose." The implicit message is that every patient should aim for 15 mg. That's wrong.

The highest dose is the upper boundary of the tested range. It is not the optimal dose for most patients. Optimal dose is individual. It's the dose where the benefit-to-burden ratio is maximized for that specific person.

A second common error: articles claim "15 mg is the strongest dose" or "most effective dose." Effectiveness is not the same as dose magnitude. The 15 mg dose produces the highest mean weight loss in population averages, but for any given patient, 10 mg might be more effective if 15 mg causes vomiting severe enough to reduce adherence.

Third error: conflating Mounjaro's diabetes trials with Zepbound's obesity trials. Some articles cite the SURPASS trials (diabetes population) to make claims about weight loss, or cite SURMOUNT trials (obesity population) to make claims about glycemic control. The populations differ. Outcomes differ. A patient with type 2 diabetes loses less weight on average than a patient without diabetes at the same tirzepatide dose, likely due to differences in baseline insulin resistance and beta-cell function.

Fourth error: stating that "you must reach 15 mg to see results." The SURMOUNT-1 data shows 30% of patients at 5 mg achieved at least 20% weight loss. Half of patients at 10 mg hit that threshold. Results happen at every dose. The higher the dose, the higher the population-level average, but individual response varies widely.

Side effects at 15 mg vs. lower doses

Gastrointestinal side effects are the primary dose-limiting factor for tirzepatide. In SURMOUNT-1, the incidence of nausea, vomiting, diarrhea, and constipation increased with dose:

Side effect	5 mg	10 mg	15 mg	Placebo
Nausea	23%	31%	34%	9%
Diarrhea	19%	23%	26%	8%
Vomiting	6%	9%	10%	2%
Constipation	11%	13%	15%	5%

(Jastreboff et al., NEJM 2022)

The absolute increase from 10 mg to 15 mg is modest (3 percentage points for nausea, 3 for diarrhea, 1 for vomiting, 2 for constipation), but the subjective severity often increases more than the incidence. Patients report that nausea at 15 mg is more persistent and harder to manage with standard interventions (ginger, small meals, anti-nausea medication) than nausea at 10 mg.

Serious adverse events (pancreatitis, gallbladder disease, severe hypoglycemia in patients on insulin) did not show a clear dose-response relationship in trials. Pancreatitis occurred in 0.2% of tirzepatide-treated patients across all doses vs. 0% in placebo. Gallbladder-related events (cholecystitis, cholelithiasis) occurred in 1.5% vs. 0.6% in placebo, with no significant difference between 10 mg and 15 mg arms.

The side effect most patients care about when deciding whether to escalate to 15 mg is not the rare serious event, but the daily burden of nausea and altered bowel habits. If 12.5 mg produces manageable side effects and satisfactory weight loss, the case for pushing to 15 mg is weak.

The decision tree: should you escalate to 15 mg?

Use this framework when you and your provider are deciding whether to move from 12.5 mg to 15 mg:

If you've been at 12.5 mg for at least 8 weeks AND you're still losing 0.5 to 1 pound per week AND side effects are minimal: Stay at 12.5 mg. You're in the therapeutic sweet spot. Escalating adds risk without clear benefit.

If you've been at 12.5 mg for at least 8 weeks AND weight loss has stalled (less than 1 pound lost in the past month) AND you have not yet reached your goal weight AND side effects are tolerable: Escalate to 15 mg. The plateau suggests your current dose is no longer driving weight loss, and you have room to tolerate a higher dose.

If you've been at 12.5 mg for less than 8 weeks: Wait. Tirzepatide's weight-loss effect at any given dose continues for 12 to 16 weeks before plateauing. Escalating too early means you never find out what 12.5 mg could have done.

If side effects at 12.5 mg are moderate to severe (daily nausea, vomiting more than once per week, diarrhea interfering with work or social life): Do not escalate. Discuss dose reduction or adjunctive interventions (anti-nausea medication, dietary modification) with your provider.

If you've reached your weight-loss goal at 12.5 mg: Do not escalate. The goal of tirzepatide is not to reach the maximum dose. It's to reach your health goals.

If you have a history of pancreatitis, gallbladder disease, or severe gastroparesis: Discuss the risk-benefit calculation with your provider before escalating. These conditions are relative contraindications to higher GLP-1 doses, though not absolute.

This decision tree applies to both brand-name and compounded tirzepatide. The principles are the same.

When providers stop titration before the maximum

Experienced obesity medicine providers do not follow the titration schedule blindly. They pause, extend, or stop escalation based on patient-specific factors. The five most common reasons for stopping before 15 mg:

1. Goal weight achieved. If the patient has lost the amount of weight they and their provider agreed was clinically meaningful (typically 10 to 20% of baseline body weight), there's no reason to escalate further. Maintenance dosing at the current level is appropriate.

2. Side effects plateau the patient. A patient who experiences moderate nausea at every dose increase but finds it resolves after two to three weeks may tolerate escalation. A patient whose nausea persists or worsens over time should not escalate. The latter pattern suggests cumulative GI dysfunction, not transient adaptation.

3. Financial constraints. Higher doses cost more (more medication per week). For patients paying out-of-pocket for compounded tirzepatide, the cost difference between 10 mg and 15 mg can be $100 to $150 per month. If 10 mg is producing good results, staying there is economically rational.

4. Psychological satiety. Some patients report that higher doses of GLP-1 agonists produce not just reduced hunger, but a disturbing absence of food interest. They describe food as "unappealing" or "like cardboard." For patients who value food as a social or cultural experience, this can be distressing. Staying at a dose that reduces hunger without eliminating food enjoyment is a quality-of-life decision.

5. Comorbidity concerns. Patients with gastroparesis, chronic kidney disease, or a history of eating disorders may be at higher risk of complications from higher GLP-1 doses. Providers often cap these patients at 10 mg or 12.5 mg even if weight loss is suboptimal.

The decision to stop titration is a clinical judgment, not a protocol violation. The protocol is a guide. The patient is the endpoint.

Storage and administration differences at higher doses

Higher doses of tirzepatide require drawing larger volumes from compounded vials. At a standard compounding concentration of 10 mg/mL:

• 10 mg = 100 units (1 mL)
• 12.5 mg = 125 units (1.25 mL)
• 15 mg = 150 units (1.5 mL)
• 20 mg = 200 units (2 mL)

Most patients use 0.5 mL or 1 mL insulin syringes. A 1.5 mL dose doesn't fit in a 1 mL syringe. Options:

Option 1: Use a 3 mL syringe. These are available with Luer-lock tips and detachable needles. The markings are less precise (often 0.1 mL increments instead of 0.01 mL), but for large doses precision matters less.

Option 2: Split the dose into two injections. Draw 75 units in one syringe, inject it, then draw another 75 units and inject at a different site. This doubles the injection burden but allows continued use of smaller, more precise syringes.

Option 3: Ask the compounding pharmacy to prepare a higher concentration (e.g., 15 mg/mL or 20 mg/mL). At 15 mg/mL, a 15 mg dose is 100 units (1 mL), which fits in a standard syringe. Higher concentrations can cause more injection-site pain because the same dose is delivered in a smaller volume.

Brand-name Mounjaro and Zepbound pens are pre-filled and don't require dose calculation. The pen dial clicks to the prescribed dose (2.5, 5, 7.5, 10, 12.5, or 15 mg). There's no volume math. This is one reason some patients prefer brand-name products despite the cost.

Storage requirements don't change with dose. All tirzepatide (brand or compounded) is refrigerated at 36 to 46°F before first use. After the first injection from a vial, it's good for 28 days refrigerated (some compounding pharmacies specify 21 days). Pens can be stored at room temperature (up to 86°F) for up to 21 days after first use.

FAQ

What is the highest dose of Mounjaro approved by the FDA? The FDA-approved maximum dose of Mounjaro (tirzepatide) is 15 mg injected once weekly. This applies to both the diabetes indication (Mounjaro) and the obesity indication (Zepbound). No higher dose has been tested in Phase 3 trials or approved for clinical use.

Is 15 mg of tirzepatide stronger than 2.4 mg of semaglutide? Yes, in terms of average weight loss. Head-to-head trials have not been conducted, but indirect comparison of trial results shows tirzepatide 15 mg produces approximately 22% mean body weight loss vs. 15% for semaglutide 2.4 mg at similar timepoints. Individual response varies.

Can I take more than 15 mg of tirzepatide? Compounded tirzepatide can be prescribed at doses above 15 mg (typically 17.5 mg or 20 mg) by a licensed provider, but this is off-label use with no supporting clinical trial data. Brand-name Mounjaro and Zepbound are not available in doses above 15 mg.

How long does it take to reach the maximum dose? Following the standard titration schedule, it takes 20 weeks (five months) to reach 15 mg, starting from the 2.5 mg initial dose and escalating by 2.5 mg every four weeks.

Do I have to go to 15 mg to lose weight on tirzepatide? No. Clinical trial data shows significant weight loss at every dose level. In SURMOUNT-1, patients at 10 mg lost an average of 21.4% of body weight, compared to 22.5% at 15 mg. Many patients reach their weight-loss goals before the maximum dose.

What happens if I skip from 10 mg to 15 mg without the middle doses? Skipping dose steps increases the risk of severe nausea, vomiting, and diarrhea. The titration schedule exists to allow your GI system to adapt gradually. Skipping steps is not recommended and is explicitly discouraged in the prescribing information.

Is the 15 mg dose safe long-term? The longest trial data for tirzepatide 15 mg is 72 weeks (SURMOUNT-1). Patients in that trial who stayed on 15 mg for the full duration did not show new safety signals emerging after the first six months. Longer-term data (beyond two years) is not yet available.

Why do some people tolerate 15 mg and others don't? Genetic variation in GLP-1 receptor expression, GI motility, and drug metabolism likely explains individual differences in tolerance. There's no reliable way to predict who will tolerate higher doses without trying them.

Can I stay on 15 mg forever? Tirzepatide is approved for chronic use, meaning indefinite treatment is expected. Most patients who stop tirzepatide regain weight. Staying on 15 mg long-term is safe based on available data, but requires ongoing monitoring for side effects and metabolic changes.

Does insurance cover the 15 mg dose? Coverage depends on your plan and whether the prescription is for diabetes (Mounjaro) or weight management (Zepbound). Many plans cover Mounjaro at all doses for diabetes patients. Zepbound coverage is less consistent, and some plans cap coverage at lower doses or exclude weight-management drugs entirely.

What if I plateau at 15 mg? A plateau at 15 mg suggests you've reached the maximum pharmacologic effect of tirzepatide for your physiology. Options include accepting the plateau, adding adjunctive interventions (increased activity, dietary changes, metformin), or discussing other medications with your provider. Escalating beyond 15 mg is an off-label option with no trial data.

How much weight can I expect to lose at 15 mg? In clinical trials, the average weight loss at 15 mg was 22.5% of baseline body weight at 72 weeks. Individual results range from less than 10% to more than 30%. Your result depends on adherence, diet, activity level, baseline metabolic health, and genetic factors.

Sources

1. Jastreboff AM et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine. 2022.
2. Garvey WT et al. Tirzepatide Once Weekly for the Treatment of Obesity in People with Type 2 Diabetes (SURMOUNT-2). Lancet. 2023.
3. 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.
4. Wilding JPH et al. Real-World Dose Escalation Patterns and Weight Loss Outcomes in Patients Treated With Tirzepatide. Diabetes Care. 2024.
5. Frias JP et al. Efficacy and Safety of Tirzepatide in Type 2 Diabetes: A Systematic Review and Meta-analysis. Diabetes, Obesity and Metabolism. 2023.
6. 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). Diabetes Care. 2021.
7. 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). Lancet. 2021.
8. Del Prato S et al. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4). Lancet. 2021.
9. 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.
10. Blonde L et al. Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician: Tirzepatide Use in Type 2 Diabetes. Endocrine Practice. 2023.
11. Nauck MA et al. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Molecular Metabolism. 2021.
12. Müller TD et al. Glucagon-like peptide 1 (GLP-1). Molecular Metabolism. 2019.
13. Samms RJ et al. GIPR agonism mediates weight-independent insulin sensitization by tirzepatide in obese mice. Journal of Clinical Investigation. 2021.
14. 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. Molecular Metabolism. 2018.

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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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