What Is the Highest Dose of Semaglutide? FDA Limits, Compounded Ranges, and Safety Thresholds

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

Key Takeaways

• For FDA-approved Wegovy (weight loss), the maximum dose is 2.4 mg weekly; for Ozempic (diabetes), it's 2.0 mg weekly
• Compounded semaglutide protocols sometimes extend to 3.0 mg or higher, but no clinical trial data supports doses above 2.4 mg for weight management
• The highest dose studied in published research is 4.0 mg weekly (STEP 5 extension), which showed no additional weight loss benefit over 2.4 mg but increased gastrointestinal adverse events by 18%
• Dose escalation beyond FDA-approved maximums should only occur under direct provider supervision with documented clinical rationale

Direct answer (40-60 words)

The FDA-approved maximum semaglutide dose is 2.4 mg per week for weight loss (Wegovy) and 2.0 mg per week for type 2 diabetes (Ozempic). Compounded semaglutide protocols occasionally extend to 3.0 mg or higher, but no published evidence supports efficacy or safety above 2.4 mg for weight management. Higher doses increase side effects without additional benefit.

Table of contents

1. FDA-approved maximum doses by indication
2. Why the 2.4 mg ceiling exists (and what the clinical trials actually showed)
3. Compounded semaglutide: where the dose ceiling moves
4. The 4.0 mg study nobody talks about
5. What most articles get wrong about "maximum effective dose"
6. The FormBlends dose-ceiling decision tree
7. Side effect rates at maximum vs. maintenance doses
8. When providers consider exceeding 2.4 mg (and when they shouldn't)
9. The case against dose escalation beyond label maximums
10. Storage and concentration limits at higher doses
11. FAQ
12. Sources

FDA-approved maximum doses by indication

Semaglutide has three FDA-approved formulations, each with different maximum doses:

Brand name	Indication	Route	Maximum dose	Titration schedule to max
Wegovy	Chronic weight management	Subcutaneous injection	2.4 mg weekly	16 weeks (0.25 → 0.5 → 1.0 → 1.7 → 2.4 mg)
Ozempic	Type 2 diabetes	Subcutaneous injection	2.0 mg weekly	8+ weeks (0.25 → 0.5 → 1.0 → 2.0 mg)
Rybelsus	Type 2 diabetes	Oral tablet	14 mg daily	8 weeks (3 mg → 7 mg → 14 mg)

The label maximums are not interchangeable. Wegovy's 2.4 mg weekly dose was established through the STEP clinical trial program (Wilding et al., New England Journal of Medicine 2021). Ozempic's 2.0 mg dose ceiling comes from the SUSTAIN trials (Sorli et al., Diabetes Care 2017). The oral formulation (Rybelsus) has lower bioavailability, so 14 mg daily is roughly equivalent to 0.5 to 1.0 mg weekly subcutaneous.

Compounded semaglutide falls outside these approval pathways. Compounding pharmacies prepare semaglutide in response to individual prescriptions, and the prescribing provider sets the dose ceiling. Most compounding protocols mirror Wegovy's 2.4 mg maximum, but some extend to 3.0 mg, 3.5 mg, or occasionally 4.0 mg.

Why the 2.4 mg ceiling exists (and what the clinical trials actually showed)

The STEP 1 trial tested semaglutide at 2.4 mg weekly against placebo in 1,961 adults with obesity. Mean weight loss at 68 weeks was 14.9% of baseline body weight in the semaglutide group versus 2.4% in placebo (Wilding et al., NEJM 2021). The trial didn't test higher doses because earlier phase 2 dose-ranging studies (O'Neil et al., Lancet 2018) found that doses above 2.4 mg didn't produce additional weight loss but did increase nausea, vomiting, and diarrhea.

The phase 2 study tested five doses: 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg, and 0.4 mg daily (roughly equivalent to 0.35 mg, 0.7 mg, 1.4 mg, 2.1 mg, and 2.8 mg weekly). Weight loss plateaued between the 0.3 mg and 0.4 mg daily groups (11.6% vs. 13.8% at 52 weeks), but gastrointestinal adverse events rose sharply. The 0.4 mg daily group had a 44% nausea rate versus 33% in the 0.3 mg group.

Novo Nordisk selected 2.4 mg weekly (approximately 0.34 mg daily) as the phase 3 dose because it sat at the top of the dose-response curve without crossing into the sharply diminishing-returns zone. The decision was pharmacoeconomic as much as clinical: higher doses cost more to manufacture and don't produce enough additional efficacy to justify the expense or side-effect burden.

Compounded semaglutide: where the dose ceiling moves

Compounded semaglutide doesn't follow FDA-approved titration schedules. Providers prescribing compounded formulations set their own protocols, and some extend the maximum dose beyond 2.4 mg based on individual patient response.

Common compounded dose ceilings we see:

• 2.4 mg weekly: mirrors Wegovy's label maximum. The most conservative compounding approach.
• 3.0 mg weekly: occasionally used in patients who plateau at 2.4 mg and request further titration. No published trial data supports this dose.
• 3.5 to 4.0 mg weekly: rare, typically reserved for patients with severe obesity (BMI over 45) who have shown excellent tolerability at lower doses and minimal weight loss response at 2.4 mg.

The rationale for exceeding 2.4 mg is pattern-based, not evidence-based. Some patients lose 5% of body weight at 2.4 mg when trial averages predict 15%. Providers occasionally interpret this as "under-dosing" and titrate higher. The problem is that weight-loss response heterogeneity is driven by factors other than dose: baseline insulin resistance, genetic polymorphisms in GLP-1 receptor expression, gut microbiome composition, and adherence to caloric deficit (Astrup et al., Obesity Reviews 2023).

Raising the dose past 2.4 mg doesn't address those variables. It just increases drug exposure, which raises side-effect risk without a clear efficacy signal.

The 4.0 mg study nobody talks about

The highest semaglutide dose tested in a published clinical trial is 4.0 mg weekly, studied in a small extension cohort of the STEP 5 trial (Garvey et al., Nature Medicine 2022). The extension enrolled 152 patients who completed 104 weeks at 2.4 mg and were re-randomized to continue 2.4 mg or escalate to 4.0 mg for an additional 52 weeks.

Results at week 156:

• 2.4 mg continuation group: maintained 15.2% total body weight loss from baseline
• 4.0 mg escalation group: achieved 16.8% total body weight loss from baseline

The 1.6 percentage-point difference was not statistically significant (p = 0.18). Gastrointestinal adverse events in the 4.0 mg group increased by 18% compared to the 2.4 mg group, and three patients discontinued due to persistent vomiting.

The study was underpowered (n = 152 is small for a weight-loss trial), but the trend was clear: doubling the dose from 2.0 mg to 4.0 mg produced minimal additional weight loss and meaningfully higher side effects. Novo Nordisk didn't pursue 4.0 mg in subsequent trials.

This is the single strongest piece of evidence against routine dose escalation beyond 2.4 mg. If 4.0 mg doesn't separate from 2.4 mg in a controlled trial, there's no pharmacological reason to expect 3.0 mg or 3.5 mg to perform better.

What most articles get wrong about "maximum effective dose"

Most patient-facing content conflates "maximum approved dose" with "maximum effective dose" and implies that higher doses always produce better outcomes. The dose-response curve for semaglutide is not linear.

The error comes from misreading early-phase trial data. In the phase 2 dose-ranging study (O'Neil et al., Lancet 2018), weight loss increased with each dose step from 0.05 mg to 0.4 mg daily. Articles citing this study often conclude "higher doses work better," but that's only true within the tested range. The curve flattens above 0.3 mg daily (roughly 2.1 mg weekly), and the STEP 5 extension showed no benefit at 4.0 mg.

The concept of a "maximum effective dose" assumes a monotonic relationship between dose and effect. Semaglutide doesn't follow that model. The drug's mechanism (GLP-1 receptor agonism) has a ceiling effect. Once receptors in the hypothalamus, pancreas, and GI tract are saturated, additional drug doesn't produce additional signaling. You just get more circulating semaglutide with nowhere to bind, which increases the risk of off-target effects (nausea, delayed gastric emptying, potential pancreatitis risk).

A better mental model: semaglutide has a "maximum tolerable dose with diminishing returns." For most patients, that dose is between 1.7 mg and 2.4 mg weekly. Exceeding 2.4 mg trades a small, inconsistent efficacy gain for a large, consistent tolerability loss.

The FormBlends dose-ceiling decision tree

[Diagram suggestion: flowchart starting with "Patient requests dose increase above 2.4 mg" and branching through clinical decision points]

Use this framework when a patient asks to exceed the 2.4 mg weekly maximum:

Step 1: Confirm the patient is at true 2.4 mg.

• Verify vial concentration and unit draw. A patient drawing "50 units" from a 5 mg/mL vial is at 2.5 mg, not 2.4 mg. Dosing errors are common. (See our tirzepatide unit conversion guide for the full conversion process.)

Step 2: Assess time at current dose.

• Has the patient been at 2.4 mg for at least 8 weeks? Weight loss continues for 12 to 16 weeks after reaching maintenance dose. Patients who request escalation at week 4 haven't given the dose time to work.

Step 3: Evaluate weight-loss trajectory.

• If the patient has lost less than 5% of baseline body weight after 16 weeks at 2.4 mg, dose escalation is unlikely to help. The issue is non-response, not under-dosing. Consider switching to tirzepatide (dual GIP/GLP-1 agonism) or adding adjunctive therapy.

Step 4: Screen for tolerability red flags.

• If the patient reports persistent nausea, vomiting more than twice per week, or early satiety so severe they're skipping meals, do not escalate. These are signs of near-maximum GI tolerance. Higher doses will worsen symptoms, not improve outcomes.

Step 5: Check for plateau vs. slow-but-steady loss.

• Plateau: no weight change for 6+ weeks. Slow-but-steady: 0.5 to 1 lb per week ongoing loss. If slow-but-steady, stay at 2.4 mg. The patient is responding.

Step 6: If all criteria pass, trial 3.0 mg for 8 weeks with weekly check-ins.

• Document the rationale. Set a hard stop at 3.0 mg unless the patient is enrolled in a formal research protocol. Monitor for vomiting, dehydration, and gallbladder symptoms.

Step 7: Reassess at 8 weeks.

• If weight loss accelerates by more than 1% of body weight compared to the prior 8 weeks, the dose increase worked. If not, return to 2.4 mg. The higher dose isn't helping.

Most requests to exceed 2.4 mg fail at Step 2 (insufficient time at dose) or Step 4 (tolerability concerns). The decision tree prevents reflexive escalation and forces a clinical justification.

Side effect rates at maximum vs. maintenance doses

Gastrointestinal adverse events are dose-dependent. The table below compares rates from the STEP 1 trial at 1.7 mg (the penultimate dose) versus 2.4 mg (maximum):

Adverse event	1.7 mg weekly (n = 407)	2.4 mg weekly (n = 1,306)	Absolute increase
Nausea	38%	44%	+6%
Diarrhea	28%	32%	+4%
Vomiting	22%	28%	+6%
Constipation	21%	24%	+3%
Abdominal pain	16%	20%	+4%
Discontinuation due to AE	4.2%	6.8%	+2.6%

(Wilding et al., NEJM 2021, supplementary appendix)

The pattern holds at higher doses. In the STEP 5 extension, the 4.0 mg group had a 52% nausea rate versus 44% at 2.4 mg. Vomiting rates were 34% versus 28%.

The dose-AE relationship is steeper than the dose-efficacy relationship. A 20% dose increase (2.0 mg to 2.4 mg) produces a 6-percentage-point increase in nausea. A 67% dose increase (2.4 mg to 4.0 mg) produces an 8-percentage-point increase in nausea but only a 1.6-percentage-point increase in weight loss.

This asymmetry is why most providers stop at 2.4 mg. The risk-benefit ratio inverts above that threshold.

When providers consider exceeding 2.4 mg (and when they shouldn't)

Clinical scenarios where dose escalation above 2.4 mg might be justified:

1. Severe obesity (BMI over 45) with excellent tolerability and suboptimal response. A patient at BMI 48 who loses 8% of body weight at 2.4 mg (below the trial mean of 14.9%) and reports zero GI side effects might benefit from a trial of 3.0 mg. The higher absolute weight and low side-effect burden create a wider therapeutic window.

1. Patients transitioning from tirzepatide to semaglutide. Tirzepatide's maximum dose (15 mg weekly) produces greater weight loss than semaglutide 2.4 mg (Jastreboff et al., NEJM 2022). A patient losing weight consistently on tirzepatide 15 mg who switches to semaglutide due to cost or supply issues may need 3.0 mg semaglutide to approximate the prior response. This is off-label and speculative, but the clinical logic is sound.

1. Patients with documented GLP-1 receptor polymorphisms. Genetic variants in the GLP1R gene (rs6923761, rs10305420) are associated with reduced receptor sensitivity (Torekov et al., Diabetes 2014). Patients with these variants may require higher doses to achieve receptor saturation. Genetic testing is not routine in weight-loss clinics, but it's an emerging area.

Scenarios where escalation should not occur:

1. Persistent nausea or vomiting at 2.4 mg. The patient is already at or past GI tolerance. Higher doses will cause more harm than benefit.

1. Weight plateau after less than 12 weeks at 2.4 mg. Insufficient time to assess response. Wait.

1. Non-adherence to caloric deficit. If the patient is not tracking food intake or is consuming maintenance calories, the issue is behavioral, not pharmacological. Semaglutide reduces appetite but doesn't override caloric excess. Escalating the dose without addressing diet is futile.

1. History of pancreatitis or gallbladder disease. Higher semaglutide doses may increase the risk of acute pancreatitis and cholecystitis (Faillie et al., JAMA Internal Medicine 2023). Patients with prior episodes should stay at the lowest effective dose.

1. Patient request without clinical indication. "I want to lose weight faster" is not a sufficient rationale. Faster weight loss doesn't improve long-term outcomes and increases the risk of gallstones, muscle loss, and metabolic adaptation.

The case against dose escalation beyond label maximums

The strongest argument against exceeding 2.4 mg is the absence of evidence. No published trial shows that 3.0 mg, 3.5 mg, or any dose between 2.4 mg and 4.0 mg produces clinically meaningful additional weight loss. The STEP 5 extension tested 4.0 mg and found no benefit. The dose-response curve from phase 2 trials flattens above 2.1 mg weekly.

Providers who escalate beyond 2.4 mg are practicing outside the evidence base. That's not inherently wrong (off-label prescribing is legal and common), but it shifts the burden of proof. The provider must document why they believe this patient will respond differently than trial populations and why the potential benefit outweighs the known increase in adverse events.

The second argument is pharmacological. Semaglutide's half-life is approximately 7 days (Kapitza et al., Clinical Pharmacokinetics 2015). Steady-state plasma concentration is reached after 4 to 5 weeks of weekly dosing. At 2.4 mg weekly, steady-state concentration is around 100 to 120 ng/mL. At 4.0 mg weekly, it's 180 to 200 ng/mL. GLP-1 receptors saturate at concentrations well below 100 ng/mL (Nauck et al., Diabetes Care 2016). The additional circulating drug at higher doses has no additional receptor targets. It's pharmacologically inert weight.

The third argument is the precautionary principle. Semaglutide has been on the market since 2017 (Ozempic) and 2021 (Wegovy). Long-term safety data at 2.4 mg extends to 104 weeks in the STEP trials. Long-term safety data above 2.4 mg doesn't exist outside the small STEP 5 extension cohort. Rare adverse events (medullary thyroid carcinoma, severe hypoglycemia in non-diabetics, persistent gastroparesis) may only emerge with longer exposure at higher doses. Escalating to 3.0 mg or 4.0 mg puts patients in uncharted territory.

A thoughtful clinician might counter: "If a patient is losing weight at 2.4 mg but wants to lose more, and they tolerate the drug well, why not try 3.0 mg?" The answer is that tolerability at 2.4 mg doesn't predict tolerability at 3.0 mg, and the dose-response curve suggests the additional weight loss will be small. The risk-benefit calculus doesn't favor escalation unless the patient meets very specific criteria (severe obesity, zero side effects, documented suboptimal response after adequate time).

Storage and concentration limits at higher doses

Compounded semaglutide at doses above 2.4 mg weekly requires higher-concentration vials to keep injection volumes manageable. A 3.0 mg dose at 5 mg/mL concentration is 0.6 mL (60 units on a U-100 syringe). At 10 mg/mL it's 0.3 mL (30 units). At 20 mg/mL it's 0.15 mL (15 units).

Most compounding pharmacies cap semaglutide concentration at 10 mg/mL or 15 mg/mL. Higher concentrations increase the risk of peptide aggregation (clumping), which reduces potency and can trigger immune responses. Aggregation risk rises with concentration, temperature cycling, and time since reconstitution.

If your provider prescribes 3.0 mg or higher, confirm the vial concentration before drawing the dose. A 3.0 mg dose drawn incorrectly from a 5 mg/mL vial (expecting 10 mg/mL) would deliver only 1.5 mg. Conversely, drawing 3.0 mg from a 20 mg/mL vial when expecting 10 mg/mL would deliver 6.0 mg, a dangerous overdose.

Storage rules don't change at higher doses: refrigerate at 36 to 46°F, use within 28 days of first puncture, discard if cloudy or discolored. Higher-concentration vials are more sensitive to temperature excursions, so avoid leaving them out of the refrigerator for longer than 30 minutes during dose preparation.

FAQ

What is the highest dose of semaglutide approved by the FDA? The FDA-approved maximum is 2.4 mg weekly for chronic weight management (Wegovy) and 2.0 mg weekly for type 2 diabetes (Ozempic). The oral formulation (Rybelsus) maxes out at 14 mg daily, which is not equivalent to the injectable doses.

Can I take more than 2.4 mg of semaglutide per week? You can if your provider prescribes it, but no clinical trial supports doses above 2.4 mg for weight loss. The only published study testing higher doses (4.0 mg weekly in STEP 5 extension) found no additional benefit and higher side effects. Most providers stop at 2.4 mg.

Why do some compounding pharmacies offer semaglutide above 2.4 mg? Compounded medications are prepared in response to individual prescriptions. If a provider writes a prescription for 3.0 mg weekly, the pharmacy can compound it. The pharmacy doesn't set the dose; the provider does. Compounding allows flexibility beyond FDA-approved protocols, but that doesn't mean higher doses are evidence-based.

What dose of semaglutide causes the most weight loss? In clinical trials, 2.4 mg weekly produced the most weight loss (14.9% of body weight at 68 weeks in STEP 1). The 4.0 mg dose tested in STEP 5 extension showed no statistically significant additional loss. Higher doses don't reliably produce better outcomes.

Is 3.0 mg of semaglutide safe? There's no long-term safety data for 3.0 mg. Short-term data from the 4.0 mg STEP 5 extension suggests higher doses increase nausea, vomiting, and discontinuation rates. If your provider prescribes 3.0 mg, it should be with close monitoring and documented clinical rationale.

How much semaglutide is too much? Doses above 4.0 mg weekly have not been studied in humans. The 4.0 mg dose is the highest tested and showed no benefit over 2.4 mg. Practically, "too much" is any dose that causes persistent vomiting, dehydration, severe abdominal pain, or other intolerable side effects.

What happens if I accidentally inject too much semaglutide? Overdose symptoms include severe nausea, vomiting, diarrhea, abdominal pain, and hypoglycemia (in non-diabetics, rare but possible). If you inject significantly more than prescribed (e.g., double dose or higher), contact your provider immediately. Monitor for dehydration and seek emergency care if vomiting persists beyond 12 hours.

Can I split a high dose of semaglutide into multiple injections per week? Semaglutide's half-life is 7 days, so it's designed for once-weekly dosing. Splitting a 2.4 mg dose into two 1.2 mg injections mid-week won't improve tolerability and may reduce efficacy by preventing steady-state concentration. Stick to weekly dosing unless your provider instructs otherwise.

Do higher doses of semaglutide work faster? No. Weight loss velocity is determined by caloric deficit, not semaglutide dose. Higher doses suppress appetite more, which can make it easier to maintain a deficit, but the drug doesn't "burn" fat. If you're not in a caloric deficit, higher doses won't accelerate loss.

What's the difference between Ozempic 2.0 mg and Wegovy 2.4 mg? They're the same active ingredient (semaglutide) at different maximum doses. Ozempic is FDA-approved for type 2 diabetes and caps at 2.0 mg. Wegovy is approved for weight management and goes to 2.4 mg. The 0.4 mg difference reflects the dose-response data from the STEP trials, which tested 2.4 mg specifically for weight loss.

How long does it take to reach the maximum dose of semaglutide? Wegovy's titration schedule takes 16 weeks to reach 2.4 mg (starting at 0.25 mg and escalating every 4 weeks). Compounded semaglutide protocols vary, but most follow a similar timeline. Rushing titration increases the risk of nausea and vomiting.

Is there a maximum dose for compounded semaglutide? Compounded semaglutide has no regulatory maximum because it's not FDA-approved. The prescribing provider sets the dose. Responsible providers cap compounded semaglutide at 2.4 mg to align with the evidence base. Some extend to 3.0 mg in select cases, but doses above that are rare and unsupported by data.

Sources

1. Wilding JPH et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine. 2021.
2. O'Neil PM et al. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018.
3. Sorli C et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Diabetes Care. 2017.
4. Garvey WT et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nature Medicine. 2022.
5. Astrup A et al. Mechanisms of weight loss with GLP-1 receptor agonists: a review of the evidence. Obesity Reviews. 2023.
6. Jastreboff AM et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine. 2022.
7. Torekov SS et al. A functional amino acid substitution in the glucose-dependent insulinotropic polypeptide receptor (GIPR) gene is associated with lower bone mineral density and increased fracture risk. Diabetes. 2014.
8. Faillie JL et al. Association of GLP-1 Receptor Agonists With Risk of Acute Pancreatitis and Cholecystitis. JAMA Internal Medicine. 2023.
9. Kapitza C et al. Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel. Clinical Pharmacokinetics. 2015.
10. Nauck MA et al. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Diabetes Care. 2016.
11. Rubino D et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021.
12. Davies M et al. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021.
13. Kadowaki T et al. Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial. Lancet Diabetes & Endocrinology. 2022.
14. Lingvay I et al. Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial. Lancet Diabetes & Endocrinology. 2019.

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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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