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  1. Medical Information Right
  2. Diabetes Right
  3. Mounjaro (tirzepatide) injection Right
  4. What proportion of study participants developed retinopathy during the SURPASS trials?
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Mounjaro ® (tirzepatide) injection

2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What proportion of study participants developed retinopathy during the SURPASS trials?

Diabetic retinopathy has been reported as an AE in ≤1% of participants in the SURPASS studies. However, tirzepatide has not been studied in people with non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, or diabetic macular edema.

US_cFAQ_TZP016A_M_RETINOPATHY
US_cFAQ_TZP016A_M_RETINOPATHYen-US

See important safety information, including boxed warning, in the attached prescribing information.

Prescribing Information Related to Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.1

Tirzepatide has not been studied in patients with

  • non-proliferative diabetic retinopathy requiring acute therapy,
  • proliferative diabetic retinopathy, or
  • diabetic macular edema.1 

Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.1 

Diabetic Retinopathy in SURPASS Studies

Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) for once-weekly, subcutaneous administration.1

Inclusion/Exclusion Criteria and Retinopathy at Baseline

Patients were excluded from SURPASS studies if they had pre-existing conditions such as

  • nonproliferative diabetic retinopathy requiring acute therapy
  • proliferative diabetic retinopathy, or
  • diabetic macular edema.1,2

Patients were assessed by baseline fundoscopic examination, and retinopathy was reported in 13% of the population in a pool of two placebo-controlled clinical trials.1

Patients were assessed by baseline fundoscopic examination, and retinopathy was reported in 15% of the population in a pool of seven controlled clinical trials.1

Diabetic retinopathy was reported as a pre-existing condition in 12.5% of SURPASS-6 study participants.3

Clinical Trial Experience

Treatment-emergent diabetic retinopathy has been reported in 1% or less of SURPASS-1 to 6 study participants (see Cases of Diabetic Retinopathy Reported in SURPASS Studies).2,4-8

Cases of Diabetic Retinopathy Reported in SURPASS Studies2,4-8

Studya

Tirzepatide 5 mg

Tirzepatide 10 mg

Tirzepatide 15 mg

Comparatorb

SURPASS-1

0

0

0

0

SURPASS-2

0

2 (0.4)

0

0

SURPASS-3

2 (1)

0

1 (<1%)

0

SURPASS-4

2 (<1%)

1 (<1%)

1 (<1%)

1 (<1%)

SURPASS-5

0

0

0

0

SURPASS-6

2 (0.8)

0

0

4 (0.6)

aData are n (%); Safety analyses included all randomly assigned participants who took at least 1 dose of study drug with data from the start of the treatment to end of safety follow-up period.

bComparator was placebo in SURPASS-1 and SURPASS-5 for 40 weeks. Comparator was semaglutide 1 mg once weekly in SURPASS-2 for 40 weeks. Comparator was titrated insulin degludec in SURPASS-3 for 52 weeks. Comparator was titrated insulin glargine in SURPASS-4 for 52 weeks. Comparator was titrated insulin lispro in SURPASS-6 for 52 weeks.

Adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice, due to the varying conditions clinical trials are conducted under.1

Enclosed Prescribing Information

MOUNJARO® (tirzepatide) injection, for subcutaneous use, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.

2Rosenstock J, Frías JP, Rodbard HW, et al. Tirzepatide vs insulin lispro added to basal insulin in type 2 diabetes: the SURPASS-6 randomized clinical trial. JAMA. 2023;330(17):1631-1640. https://doi.org/10.1001/jama.2023.20294

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Rosenstock J, Wysham C, Frías JP, 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;398(10295):143-155. https://doi.org/10.1016/S0140-6736%2821%2901324-6

5Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. https://doi.org/10.1056/NEJMoa2107519

6Ludvik B, Giorgino F, Jódar E, 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;398(10300):583-598. https://doi.org/10.1016/S0140-6736(21)01443-4

7Del Prato S, Kahn SE, Pavo I, et al; SURPASS-4 Investigators. 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;398(10313):1811-1824. https://doi.org/10.1016/S0140-6736(21)02188-7

8Dahl D, Onishi Y, Norwood P, 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;327(6):534-545. https://doi.org/10.1001/jama.2022.0078

Date of Last Review: September 01, 2023

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