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| **1667-P\ |
| Patient-Reported Outcomes in Adults Initiating Treatment with Tirzepatide or Intensified Conventional Care Early In the Course of T2D: Results After 2 Years of Treatment in SURPASS-EARLY** |
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| Kristina Boye 1 , Palash Sharma 1 , Arkopal Choudhury 1 , Elisa Gomez 1 , Suzanne Williamson 2 , Vivian Thieu 1\ |
| 1 Eli Lilly and Company, Indianapolis, IN, USA\ |
| 2 Greenwich HE\&OR Ltd., London, UK |
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| # Sponsored by Eli Lilly and Company |
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| Objective |
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| - We evaluated the HRQoL of adults recently diagnosed with T2D (within 4 years) treated with tirzepatide 15 mg or |
| MTD, or ICC, in SURPASS-EARLY over a 2-year timeframe. |
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| Conclusions |
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| - In addition to the primary findings of improved HbA1c and weight, 1 tirzepatide treatment significantly improved overall physical and |
| psychosocial health and functioning, and weight-related quality of life after 2 years of treatment, specifically the ability to perform daily activities |
| and self-perception, compared with existing treatment options in adults who initiated treatment early in the course of T2D in the SURPASS-EARLY trial |
| - Although diabetes management focuses on the prevention of complications via control of glucose levels, weight, cardiovascular risk, and cardiorenal |
| damage, 2 improving and maintaining health-related quality of life may be of equal importance to patients |
| |
| **Limitations** |
| |
| - The PROs were administered in a clinical trial setting; therefore, results may not reflect those that may be observed in a real-world setting |
| - The open-label study design may have influenced participants to over or underestimate their treatment assessments based on their beliefs regarding |
| assigned treatment |
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| Introduction |
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| - The UKPDS longitudinal study identified a 'legacy effect' in which early glycemic control following the diagnosis of T2D led to long-term improvement in key clinical outcomes 3–5 |
| - Tirzepatide is a long-acting dual GIP/GLP-1 RA for the treatment of T2D 6 and obesity 7 that has shown greater improvement in glycemic control than GLP-1 RAs in clinical trials of T2D 8,9 |
| - SURPASS-EARLY was designed to test the hypothesis that initiation of tirzepatide early after T2D diagnosis could establish better and more durable glycemic control than ICC over a 4-year planned study 1 |
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| Methods – Study Design |
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| - A Phase 4, randomized, open-label, parallel-group, multicenter, multinational study of the long-term efficacy and |
| safety of tirzepatide vs. ICC |
| - Adults diagnosed with T2D within the last 4 years, inadequately controlled with diet, exercise, and metformin were |
| randomized (1:1) to tirzepatide 15 mg or MTD, or ICC, for 4 years |
| - ICC treatments included a range of GLMs approved for the treatment of T2D (except tirzepatide) in accordance with |
| guidelines and local product labels. Dosing was individualized to safely achieve optimal glycemic control (within a |
| non-diabetic range) |
| - Primary endpoint was change from baseline in HbA1c (%) (non-inferiority) at Week 104; key secondary endpoints |
| included change from baseline in weight (kg) (superiority) at Week 104 |
| - HRQoL was measured at baseline and Weeks 56 and 104 using four PRO measures |
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| Methods – Statistical Analyses |
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| - PRO analyses were performed on the randomized population using data prior to treatment discontinuation and without |
| use of rescue medication (efficacy estimand) |
| - MMRMs assessed changes from baseline to Weeks 56 and 104, for each PRO measure: IWQOL-Lite-CT, SF-36v2, APPADL, and |
| IW-SP |
| - Only randomized participants with a non-missing baseline value and at least one non-missing post-baseline value of |
| the response variable were included in the analysis |
| - IWQOL-Lite-CT composite and total, and APPADL and IW-SP total raw scores were transformed to a score from 0–100 and |
| positive changes in scores indicate better outcomes for all PRO measures |
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| Results |
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| - In SURPASS-EARLY, 794 participants were randomized to study treatment (398 to tirzepatide 15 mg or MTD, and 396 to ICC) 1 |
| - At baseline, mean (SD) age was 53.5 (10.3) years, T2D duration was 2.6 (1.6) years, HbA1c was 7.81 (0.82)%, and BMI was 35.4 (5.5) |
| kg/m2 ; 50.6% of participants were male, 81.5% were white, and 45.9% were of Hispanic or Latino ethnicity |
| - At Week 104, the ICC medications were GLP-1 RAs (85.3%), SGLT-2 inhibitors (16.7%), SUs (3.2%), insulin (2.6%), and DPP4 inhibitors |
| (2.0%) |
| - Tirzepatide 15 mg or MTD was superior to ICC for change from baseline in HbA1c at Week 104 (ETD -0.79%, 95% CI -0.94, -0.64; |
| p<0.001) and for change from baseline in weight at Week 104 (ETD -9.3, 95% CI -10.8, -7.9; p<0.001) |
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| Key Results |
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| Participants in the tirzepatide 15 mg or MTD group had improved transformed IWQOL-Lite-CT composite and total scores |
| vs. baseline and vs. participants in the ICC group at Weeks 56 and 104 (all p<0.05). |
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| ![SURPASS\_EARLY-key-result][image0] |
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| Tirzepatide 15 mg or MTD improved SF-36v2 Physical Functioning and Role-Physical domain scores vs. baseline and vs. |
| ICC at Weeks 56 and 104; General Health improved vs. baseline and ICC at Week 56 and vs. baseline at Week 104; Bodily |
| Pain improved vs. baseline at Week 56 (all p<0.05). |
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| Participants in the tirzepatide 15 mg or MTD group had improved SF-36v2 Vitality and Mental Health domain scores vs. |
| baseline at Weeks 56 and 104 (all p<0.05), but not vs. participants in the ICC group; improvements in the Social |
| Functioning and Role-Emotional domains were significant vs. baseline at Week 56 but not at Week 104, or vs. ICC at |
| either timepoint |
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| Participants in the tirzepatide 15 mg or MTD group had improved SF-36v2 PCS scores vs. baseline, and vs. participants |
| in the ICC group, at Weeks 56 and 104 (both p<0.05); the SF-36v2 MCS score was only improved vs. baseline in the |
| tirzepatide group at Week 56 (p<0.05). |
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| Participants in the tirzepatide 15 mg or MTD group had improved transformed APPADL and IW-SP total scores vs. |
| baseline and vs. participants in the ICC group at Weeks 56 and 104 (all p<0.05). |
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| **Figure footnotes:** \*p<0.05 vs. baseline; †p<0.05 vs. ICC. n=number of subjects in the population with value at |
| the specified time point. MMRM included treatment by visit interaction as a fixed effect, and geographic region, |
| baseline HbA1c group (≤8% or >8%), age, and baseline value as covariates. A two-sided alpha-level of 0.05 was used |
| for all statistical comparisons and the endpoints were not adjusted for multiplicity. IWQOL-Lite-CT composite and |
| total scores assessed weight-related functioning (no published MID). SF-36v2 acute form PCS and MCS, and eight domain |
| scores assessed multiple aspects of physical and mental health and functioning (MIDs: PCS, General Health, and |
| Vitality 2 points; MCS, Physical Functioning, Role Physical, Bodily Pain, Social Functioning, and Mental Health 3 |
| points; Role-Emotional 4 points). APPADL total score assessed ability to perform tasks of daily living (MID 6–14 |
| points). IW-SP total score assessed self-perception relating to body weight (MID ≥25 points). |
| |
| **Abbreviations:** APPADL, Ability to Perform Physical Activities of Daily Living; BMI, body mass index; CI, |
| confidence interval; DPP4, dipeptidyl peptidase 4; ETD, estimated treatment difference; GIP, glucose-dependent |
| insulinotropic polypeptide; GLM, glucose-lowering medication; GLP-1, glucagon-like peptide-1; HbA1c, glycated |
| hemoglobin; HRQoL, health-related quality of life; ICC, intensified conventional care; IWQOL-Lite-CT, Impact of |
| Weight on Quality of Life-Lite-Clinical Trials Version; IW-SP, Impact of Weight on Self-Perceptions; MBE, model-based |
| estimate; MCS, Mental Component Summary; MID, minimally important difference; MMRM, mixed model for repeated |
| measures; MTD, maximum tolerated dose; PRO, patient-reported outcome; PCS, Physical Component Summary; RA, receptor |
| agonist; SD, standard deviation; SF-36v2, 36-item Short Form Health Survey; SGLT-2, sodium glucose co-transporter-2; |
| SU, sulfonylurea; T2D, type 2 diabetes; UKPDS, United Kingdom Prospective Diabetes Study. |
| |
| **References** |
| |
| 1. Del Prato S, et al. Diabetes Technol Ther 2026;8(3 suppl ATTD):42S–43S |
| 2. Templer S, et al. Intern Med J 2024;45:1264–74 |
| 3. UKPDS Group. Lancet 1998;352:837–53 |
| 4. Holman RR, et al. N Engl J Med 2008;1577–89 |
| 5. Cheng AYY. Diabetes Obes Metab 2025;27:1708–18 |
| 6. Eli Lilly and Company. MOUNJARO (tirzepatide) US PI. 2024 |
| 7. Eli Lilly and Company. ZEPBOUND (tirzepatide) US PI. 2025 |
| 8. Frias JP, et al. Lancet 2018;392:2180–93 |
| 9. Frias JP, et al. N Engl J Med 2021;385:503–15 |
| |
| **Acknowledgments:** The authors would like to thank Caroline Spencer (Rx Communications, Mold, UK) for writing and |
| editorial contributions. |
| |
| **Disclosures:** Kristina Boye, Palash Sharma, Arkopal Choudhury, Elisa Gomez, and Vivian Thieu are full-time |
| employees and stock-holders of Eli Lilly and Company. Suzanne Williamson works as a consultant to Eli Lilly and |
| Company. |
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| title | Patient-Reported Outcomes in Adults Initiating Treatment with Tirzepatide or Intensified Conventional Care Early In the Course of T2D: Results After 2 |
| | Years of Treatment in SURPASS-EARLY |
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| published-time | 2026-06-10T07:46:07.254Z |
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| | "name": "Eli Lilly and Company" } }, { "@type": "Person", "name": "Elisa Gomez", |
| | "affiliation": { "@type": "Organization", "name": "Eli Lilly and Company" } }, { "@type": |
| | "Person", "name": "Suzanne Williamson", "affiliation": { "@type": "Organization", "name": "Greenwich HE\&OR |
| | Ltd.", "address": { "@type": "PostalAddress", "addressLocality": "London", "addressCountry": "GB" |
| | } } }, { "@type": "Person", "name": "Vivian Thieu", "affiliation": { |
| | "@type": "Organization", "name": "Eli Lilly and Company" } } ], "publisher": { "@type": |
| | "Organization", "name": "Eli Lilly and Company", "url": "https\://www\.lilly.com" }, "funder": { "@type": |
| | "Organization", "name": "Eli Lilly and Company" }, "citation": \[ { "@type": "CreativeWork", "name": |
| | "Del Prato S, et al. Diabetes Technol Ther 2026;8(3 suppl ATTD):42S-43S." }, { "@type": "CreativeWork", "name": |
| | "Templer S, et al. Intern Med J 2024;45:1264-74." }, { "@type": "CreativeWork", "name": "UKPDS Group. Lancet |
| | 1998;352:837-53." }, { "@type": "CreativeWork", "name": "Holman RR, et al. N Engl J Med 2008;1577-89." }, |
| | { "@type": "CreativeWork", "name": "Cheng AYY. Diabetes Obes Metab 2025;27:1708-18." }, { "@type": |
| | "CreativeWork", "name": "Eli Lilly and Company. MOUNJARO (tirzepatide) US PI. 2024." }, { "@type": "CreativeWork", |
| | "name": "Eli Lilly and Company. ZEPBOUND (tirzepatide) US PI. 2025." }, { "@type": "CreativeWork", "name": |
| | "Frias JP, et al. Lancet 2018;392:2180-93." }, { "@type": "CreativeWork", "name": "Frias JP, et al. N Engl J Med |
| | 2021;385:503-15." } ], "datePublished": "2026-06-05", "genre": "Conference Poster", "image": |
| | "https\://assets.lilly.com/congresses/ada-2026/tzp-surpass-early-pro/og-image.webp" }, { "@type": "FAQPage", "@id": |
| | "https\://www\.lilly.com/hcp/congresses/ada-2026/tzp-surpass-early-pro#faq", "mainEntity": \[ { "@type": "Question", |
| | "name": "What is the SURPASS-EARLY trial?", "acceptedAnswer": { "@type": "Answer", "text": "SURPASS-EARLY is a Phase |
| | 4, randomized, open-label, parallel-group, multicenter, multinational study testing whether initiating tirzepatide early after type 2 diabetes (T2D) |
| | diagnosis can establish better and more durable glycemic control than intensified conventional care (ICC) over 4 years. Adults diagnosed with T2D within |
| | the last 4 years, inadequately controlled with diet, exercise, and metformin, were randomized 1:1 to tirzepatide 15 mg or maximum tolerated dose (MTD) |
| | or ICC for 4 years (n=794)." } }, { "@type": "Question", "name": "Did tirzepatide improve health-related |
| | quality of life compared to conventional care in early T2D?", "acceptedAnswer": { "@type": "Answer", "text": "Yes. In |
| | SURPASS-EARLY, tirzepatide 15 mg or MTD significantly improved overall physical and psychosocial health and functioning, and weight-related quality of |
| | life after 2 years compared with intensified conventional care (ICC). Specifically, IWQOL-Lite-CT composite and total scores, SF-36v2 Physical Component |
| | Summary, APPADL (daily activities), and IW-SP (self-perception) scores were all significantly improved versus both baseline and ICC at Weeks 56 and 104 |
| | (all p<0.05)." } }, { "@type": "Question", "name": "How did tirzepatide affect SF-36v2 physical domain |
| | scores versus conventional care?", "acceptedAnswer": { "@type": "Answer", "text": "At Week 104, tirzepatide 15 mg or |
| | MTD improved SF-36v2 Physical Functioning (MBE \+3.3 vs \+1.9 for ICC) and Role-Physical (MBE \+1.6 vs \+0.3 for ICC) domain scores versus baseline and |
| | versus ICC. General Health improved versus baseline and ICC at Week 56 (MBE \+4.7 vs \+3.0) and versus baseline at Week 104 (MBE \+3.8). Bodily Pain |
| | improved versus baseline at Week 56 (MBE \+1.4). The SF-36v2 Physical Component Summary improved versus baseline and ICC at both Week 56 (MBE \+3.4 vs |
| | \+2.1) and Week 104 (MBE \+2.8 vs \+1.2) (all p<0.05)." } }, { "@type": "Question", "name": "How did |
| | tirzepatide affect SF-36v2 mental domain scores versus conventional care?", "acceptedAnswer": { "@type": "Answer", |
| | "text": "Tirzepatide 15 mg or MTD improved SF-36v2 Vitality (Week 56: MBE \+2.2; Week 104: MBE \+2.5) and Mental Health (Week 56: MBE \+1.5; Week 104: |
| | MBE \+1.4) domain scores versus baseline at both timepoints, but not versus ICC. The SF-36v2 Mental Component Summary (MCS) improved versus baseline |
| | only at Week 56 (MBE \+1.1). Social Functioning and Role-Emotional improved versus baseline at Week 56 but not at Week 104 or versus ICC at either |
| | timepoint." } }, { "@type": "Question", "name": "What were the IWQOL-Lite-CT results for tirzepatide |
| | versus ICC at 2 years?", "acceptedAnswer": { "@type": "Answer", "text": "At Week 104, tirzepatide 15 mg or MTD |
| | produced greater improvements in all IWQOL-Lite-CT scores versus ICC (all p<0.05): Physical composite MBE \+14.0 vs \+9.3; Physical Function composite |
| | MBE \+15.4 vs \+10.3; Psychosocial composite MBE \+15.4 vs \+9.9; Total MBE \+14.9 vs \+9.7. All scores were also significantly improved versus |
| | baseline." } }, { "@type": "Question", "name": "How did tirzepatide affect ability to perform daily |
| | activities and self-perception?", "acceptedAnswer": { "@type": "Answer", "text": "At Week 104, tirzepatide 15 mg or |
| | MTD significantly improved the APPADL total score (ability to perform physical activities of daily living) by MBE \+9.4 versus \+5.7 for ICC, and the |
| | IW-SP total score (impact of weight on self-perception) by MBE \+16.9 versus \+9.6 for ICC (both p<0.05 versus baseline and versus ICC at Weeks 56 and |
| | 104)." } }, { "@type": "Question", "name": "What were the primary clinical outcomes of SURPASS-EARLY at |
| | Week 104?", "acceptedAnswer": { "@type": "Answer", "text": "At Week 104, tirzepatide 15 mg or MTD was superior to ICC |
| | for change from baseline in HbA1c (estimated treatment difference –0.79%, 95% CI –0.94 to –0.64; p<0.001) and for change from baseline in weight |
| | (estimated treatment difference –9.3 kg, 95% CI –10.8 to –7.9; p<0.001)." } }, { "@type": "Question", |
| | "name": "What is tirzepatide and how does it work?", "acceptedAnswer": { "@type": "Answer", "text": "Tirzepatide |
| | (brand names Mounjaro for T2D and Zepbound for obesity) is a long-acting dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 |
| | (glucagon-like peptide-1) receptor agonist administered once weekly by subcutaneous injection. It has demonstrated greater improvement in glycemic |
| | control than GLP-1 receptor agonists in clinical trials of type 2 diabetes." } } ] }, { "@type": "BreadcrumbList", |
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