Abstract
Aims
The objective was to assess weight reduction at Weeks 24 and 72 in participants treated with tirzepatide based on weight reduction response after 12 weeks of treatment in the SURMOUNT‐1 trial.
Materials and Methods
This post hoc analysis included participants treated with tirzepatide who received ≥75% of the assigned treatment doses and had weight measurements at Weeks 0, 12, 24 and 72. Participants were categorized based on the 12‐week response to tirzepatide: late responders (<5% weight reduction at Week 12) or early responders (≥5% weight reduction at Week 12).
Results
A total of 1545 participants were included in the analyses, with 278 (18%) categorized as late responders and 1267 (82%) categorized as early responders. At baseline, late responders compared to early responders were more likely to be male (45% vs. 30%) and had higher body weight (110.2 vs. 103.6 kg), body mass index (BMI) (39.1 vs. 37.7 kg/m2) and waist circumference (117.5 vs. 113.4 cm). At the end of dose titration, Week 24, 194 (70%) late responders achieved ≥5% body weight reduction. At Week 72, 250 (90%) late responders achieved ≥5% body weight reduction. The mean time to reach 5% weight reduction for late responders was 24.8 ± 12.7 weeks. Higher doses of tirzepatide were associated with higher proportions of participants achieving various weight reduction thresholds at Weeks 24 and 72.
Conclusions
Among late responders to tirzepatide, the vast majority (90%) achieved 5% or more weight reduction at Week 72. This finding suggests that extending treatment well beyond 12 weeks may allow additional patients to achieve clinically meaningful weight reduction.
Trial Registration
ClinicalTrials.gov, identifier: NCT04184622, available at http://www.clinicaltrials.gov/.
Keywords: response, tirzepatide
1. INTRODUCTION
The goal for treating obesity is to improve patient health by preventing or improving adiposity‐related comorbidities. A weight reduction of 5% or more is typically needed to improve or prevent some of the complications of obesity, such as type 2 diabetes, dyslipidaemia, hypertension, steatohepatitis, obstructive sleep apnoea and osteoarthritis. 1 , 2 , 3 , 4 Treatment with powerful next generation obesity management medications (OMMs), like semaglutide and tirzepatide, has been shown to reduce weight in the range of 17%–23%, 5 , 6 resulting in higher percentage of resolution of metabolic dysfunction–associated steatohepatitis (MASH), 7 , 8 and lower risk of cardiovascular deaths in patients with preexisting cardiovascular disease 9 or lower risk of a composite of death from cardiovascular causes or worsening heart failure in patients with heart failure with preserved ejection fraction. 10 Additionally, treatment with tirzepatide has been associated with clinically meaningful change in sleep‐disordered breathing 11 and lower risk of progression to type 2 diabetes. 12
Some guidelines for the management of obesity suggest discontinuing OMMs that fail to produce at least a 5% weight reduction within 12 weeks. 13 , 14 These treatment guidelines were published in 2015 when highly effective OMMs were not yet available. Despite their powerful weight‐loss efficacy, newer OMMs may take longer to achieve full weight‐loss benefit given their recommended dose titration schedule, which may take up to 20 weeks to reach the maximum dose. Furthermore, the time it takes to reach weight plateau varies between individuals. 15 In a post hoc analysis of the STEP 4 trial, the majority of non‐early responders to treatment with semaglutide were able to achieve clinically relevant weight loss by the end of the study if treatment was continued. 16 Therefore, it may be reasonable to consider treatment with newer OMMs for longer than 12 weeks.
Tirzepatide is a dual receptor agonist of the human glucose‐dependent insulinotropic polypeptide (GIP) and human glucagon‐like peptide‐1 (GLP‐1) receptors approved for the treatment of chronic weight management in adults. In the SURMOUNT‐1 trial, adults with overweight or obesity achieved 16.0%, 21.4% and 22.5% weight reduction on tirzepatide 5 mg, 10 mg and 15 mg, respectively. 6 Clinically meaningful weight reduction of 5% or more was achieved by the majority of participants treated with tirzepatide (89.4%, 96.2% and 96.3%, respectively) at 72 weeks. 6 The aims of this post hoc analysis of SURMOUNT‐1 were to assess the baseline characteristics and weight reduction achieved at Weeks 24 and 72 by treatment response status at Week 12. Treatment response was defined as late responders if <5% weight reduction was achieved at Week 12 or early responders if ≥5% weight reduction was achieved at Week 12. By assessing weight‐loss patterns over time, this study provides insights into the utility of the 12‐week response threshold in guiding clinical decision making for sustained obesity treatment with tirzepatide.
2. MATERIALS AND METHODS
SURMOUNT‐1 was a phase 3, randomized, double blind, placebo‐controlled trial in adults with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with at least one weight‐related complication, excluding diabetes. Participants were assigned to receive once weekly tirzepatide or placebo. All participants received regular lifestyle counselling from a dietitian or qualified health professional to help them adhere to healthful, balanced meals, with a deficit of 500 calories per day and at least 150 minutes of physical activity per week. Tirzepatide or placebo was initiated at a dose of 2.5 mg once weekly and was increased in 2.5 mg increments every 4 weeks through the 20‐week dose escalation period. Target dose was achieved at Week 4 (5 mg), Week 12 (10 mg) or Week 20 (15 mg) based on the randomized allocation. The trial protocol and results have been previously published. 6 The trial adhered to the principles of the Declaration of Helsinki and Good Clinical Practice guidelines, receiving approval from an independent ethics committee or institutional review board at each trial site. All participants provided written informed consent prior to participation in the study.
Body weight measurements were collected in a consistent manner using a calibrated electronic scale capable of measuring weight in kilograms (kg) to one decimal place. All weights for a given participant were measured at specified intervals in a fasting state using the same scale, whenever possible, at approximately the same time in the morning.
2.1. STATISTICAL ANALYSIS
The present post hoc analyses included participants treated with tirzepatide who were adherent to treatment, defined as receiving 75% or more of the assigned treatment doses, and had weight measurement data available at Weeks 0, 12, 24 and 72. Participants were categorized based on the 12‐week response to tirzepatide (either pooling all tirzepatide doses or by dose) as follows:
<5% weight reduction at Week 12 (Late Responders)
≥5% weight reduction at Week 12 (Early Responders).
The proportions of participants reaching weight reduction targets (≥5%, ≥10%, ≥15%, ≥20%, ≥25%) at Week 24 and Week 72 were summarized descriptively. Means (standard errors, SE) of the percent weight reduction trajectory were descriptively summarized by 12‐week response subgroups, with early responders further defined by degrees of weight loss (late responders, early responders 5%–10% weight reduction and early responders ≥10% weight reduction). All the analyses were performed using SAS.
3. RESULTS
3.1. Participants
A total of 1545 participants (82% of all participants treated with tirzepatide in SURMOUNT‐1) met criteria and were included in the present analyses, with 278 (18.0%) categorized as late responders and 1267 (82.0%) categorized as early responders. Baseline demographic and clinical characteristics are shown in Table 1. At baseline, late responders compared to early responders (mean age 47 vs. 45 years) were more likely to be male (45% vs. 30%) and had higher body weight (110.2 vs. 103.6 kg), BMI (39.1 vs. 37.7 kg/m2) and waist circumference (117.5 vs. 113.4 cm) and reported a higher incidence of hypertension (45% vs. 30%). Early responders were more likely to be Hispanic or Latino (51% vs. 36%).
TABLE 1.
Baseline characteristics.
| Late Responders | Early Responders | Total | p‐value | |
|---|---|---|---|---|
| (N = 278) | (N = 1267) | (N = 1545) | ||
| Age, years | 46.7 (12.8) | 45.0 (12.0) | 45.3 (12.2) | 0.037 |
| Age ≥65 years, n (%) | 25 (9.0) | 65 (5.1) | 90 (5.8) | 0.013 |
| Male, n (%) | 124 (44.6) | 381 (30.1) | 505 (32.7) | <0.001 |
| Race, n (%) | <0.001 | |||
| White | 164 (59.0) | 927 (73.2) | 1091 (70.6) | |
| Asian | 48 (17.3) | 126 (9.9) | 174 (11.3) | |
| American Indian or Alaska Native | 32 (11.5) | 112 (8.8) | 144 (9.3) | |
| Black or African American | 30 (10.8) | 81 (6.4) | 111 (7.2) | |
| Native Hawaiian or Other Pacific Islander | 1 (0.4) | 4 (0.3) | 5 (0.3) | |
| Multiple | 3 (1.1) | 17 (1.3) | 20 (1.3) | |
| Hispanic or Latino, n (%) | 101 (36.3) | 644 (50.8) | 745 (48.2) | <0.001 |
| Weight, kg | 110.2 (24.3) | 103.6 (21.8) | 104.8 (22.4) | <0.001 |
| BMI, kg/m2 | 39.1 (7.7) | 37.7 (6.5) | 37.9 (6.7) | 0.002 |
| BMI categories, n (%) | 0.150 | |||
| <30 | 15 (5.4) | 68 (5.4) | 83 (5.4) | |
| ≥30–<35 | 88 (31.7) | 452 (35.7) | 540 (35.0) | |
| ≥35–<40 | 72 (25.9) | 366 (28.9) | 438 (28.3) | |
| ≥40 | 103 (37.1) | 381 (30.1) | 484 (31.3) | |
| Waist circumference, cm | 117.5 (16.5) | 113.4 (14.9) | 114.1 (15.3) | <0.001 |
| Prediabetes, n (%) a | 112 (40.3) | 515 (40.6) | 627 (40.6) | 0.912 |
| Obstructive sleep apnoea, n (%) | 24 (8.6) | 92 (7.3) | 116 (7.5) | 0.432 |
| Hypertension, n (%) b | 124 (44.6) | 380 (30.0) | 504 (32.6) | <0.001 |
| Systolic blood pressure, mmHg | 123.9 (12.1) | 123.5 (12.7) | 123.6 (12.6) | 0.657 |
| Diastolic blood pressure, mmHg | 78.7 (8.1) | 79.6 (8.2) | 79.5 (8.2) | 0.082 |
| Pulse, bpm | 71.5 (10.2) | 72.0 (9.5) | 71.9 (9.6) | 0.400 |
| eGFR, mL/minute/1.73 m2 c | 97.6 (17.9) | 97.8 (17.4) | 97.8 (17.5) | 0.859 |
| Duration of obesity, years | 15.1 (10.5) | 14.7 (11.1) | 14.7 (10.9) | 0.536 |
| Tirzepatide 5 mg, n (%) | 100 (36.0) | 422 (33.3) | 522 (33.8) | — |
| Tirzepatide 10 mg, n (%) | 84 (30.2) | 428 (33.8) | 512 (33.1) | — |
| Tirzepatide 15 mg, n (%) | 94 (33.8) | 417 (32.9) | 511 (33.1) | — |
Note: Data are mean (standard deviation) unless otherwise noted.
Abbreviations: BMI, body mass index; bpm, beats per minute; eGFR, estimated glomerular filtration rate.
Prediabetes defined by ADA 2019 Standards of Medical Care in Diabetes of at least 2 abnormal laboratory tests: fasting glucose 100–125 mg/dL, 2‐h glucose from oral glucose tolerance test 140–199 mg/dL, HbA1c 5.7%–6.4%.
Assessed through a review of medical history.
The estimated GFR was calculated with the use of the serum creatinine‐based Chronic Kidney Disease Epidemiology Collaboration equation.
3.2. Body weight reduction targets at Weeks 24 and 72
Four weeks after the end of the dose escalation period (Week 24), 194 (70%) late responders had a body weight reduction of 5% or more, while 84 (30%) had less than a 5% body weight reduction (Figure 1A). At Week 72, 250 (90%) late responders and 1267 (100%) early responders (by definition) had a body weight reduction of 5% or more (Figure 2A). Furthermore, 59%, 30%, 17% and 7% of the late responders and 97%, 84%, 65% and 41% of the early responders had a body weight reduction of ≥10%, ≥15%, ≥20% and ≥25% at Week 72, respectively. Higher doses of tirzepatide were associated with higher proportions of responders meeting the weight reduction targets at Weeks 24 and 72 (Figures S1 and 2B–D).
FIGURE 1.
Proportion of all tirzepatide participants achieving weight reduction targets at Week 24. The proportion of participants treated with tirzepatide who had weight reductions of at least 5%, 10%, 15%, 20% and 25% from baseline to Week 24. Error bars indicate 95% confidence intervals.
FIGURE 2.
Proportion of participants achieving weight reduction targets at endpoint (Week 72). The proportion of participants treated with tirzepatide (A), tirzepatide 5 mg (B), tirzepatide 10 mg (C) and tirzepatide 15 mg (D) who had weight reductions of at least 5%, 10%, 15%, 20% and 25% from baseline to Week 72. Error bars indicate 95% confidence intervals.
Among late responders, there were 28 participants (10%) who were ultimately classified as non‐responders, defined as less than 5% weight reduction at Week 72 (Table 2). Thirteen of the 28 non‐responders were randomized to tirzepatide 5 mg and 4 of 28 had missed more than 3 consecutive doses of tirzepatide and underwent repeat dose escalation, which resulted in decreased exposure to the assigned tirzepatide dose.
TABLE 2.
Summary of dosing parameters for non‐responders.
| Dosing parameter | Non‐responders a |
|---|---|
| (N = 28) | |
| Randomization dose | |
| Tirzepatide 5 mg | 13 (46.4) |
| Tirzepatide 10 mg | 9 (32.1) |
| Tirzepatide 15 mg | 6 (21.4) |
| Dose deviations b | |
| Dose reduction | 1 (3.6) |
| Missed ≥3 consecutive doses | 4 (14.3) |
Note: Data are number (percent).
Non‐responders were participants who had less than 5% weight reduction at Week 72.
Reported as pooled tirzepatide doses.
3.3. Percent body weight over time by 12‐week response category
At Week 72, participants achieved clinically significant weight reduction regardless of their 12‐week response category at aggregate level. The mean percent body weight reductions at Week 72 were 11.0% (−12.0 kg) for late responders and 22.5% (−23.2 kg) for early responders. Greater weight reductions at Week 12 corresponded to greater weight reduction at Week 72 (Figure 3). Higher doses of tirzepatide were associated with greater mean treatment responses, regardless of treatment response status (Figures S2–S4). For example, the mean percent body weight reduction at Week 72 for late responders was 8.3%, 11.4% and 13.6% for 5, 10 and 15 mg, respectively. Early responders had a similar pattern of response at Week 72 with higher overall weight reduction compared to late responders (18.4%, 24.1% and 24.9%). Among late responders who went on to achieve greater than 5% weight reduction at Week 72, the mean time to reach 5% weight reduction was 24.8 ± 12.7 weeks.
FIGURE 3.
The percent change in body weight from baseline to endpoint (Week 72) in all tirzepatide participants. The percent change in body weight from baseline to Week 72 according to weeks since randomization by 12‐week response subgroups with early responders further defined by degrees of weight loss (late responders, early responders 5%–10% weight reduction and early responders ≥10% weight reduction). Error bars indicate 95% confidence intervals.
4. DISCUSSION
In this post hoc analysis, 90% of the late responders to tirzepatide treatment, that is, participants who lost less than 5% body weight at Week 12, went on to achieve clinically meaningful weight reduction (≥5%) by Week 72, with 60% reaching between 5% and 15% weight reduction and 30% reaching 15% or greater weight reduction. Late responders had lower mean percent weight reduction for each tirzepatide dose compared to early responders at Week 72. Consistent with the lower weight reduction, for each categorical weight reduction target, there was a smaller proportion of late responders who achieved the target compared to early responders. Of the 1545 participants in this analysis, there was a small minority (n = 28, 1.8%) of non‐responders who lost less than 5% body weight at Week 72. Findings in this study challenge the conventional 12‐week assessment window for OMMs, suggesting that for tirzepatide, which has 20‐week dose escalation schedule to achieve the maximum dose of 15 mg, continuing treatment beyond 12 weeks may allow more patients to experience clinically meaningful weight reduction before making a determination about discontinuation or alternative interventions.
Various patient populations have been observed to respond differently to incretin therapy, and several potential mechanisms have been proposed to explain the variation in weight‐loss response to incretin therapy among individuals. Older adults may have higher odds of achieving a complete response to incretin therapy. 17 , 18 Sex also appears to play a role with females generally exhibiting a better response to incretin therapy than males. 18 , 19 , 20 , 21 , 22 As with other obesity treatments, patients with type 2 diabetes generally experience a lesser degree of weight loss compared to those without diabetes. 18 Pharmacogenomics contributes to weight‐loss variability; individuals with the CC variant of the transcription factor 7 like 2 gene (TCF7L2) demonstrated greater weight loss with liraglutide. 23 Factors related to the drug, including its potency, and increased drug exposure have been associated with greater weight loss as well. 18 , 24 , 25 Since body weight contributes to drug exposure, patients with greater body weight may experience lower drug levels in their system. 18
In the present study, a heterogeneity in weight‐loss response to tirzepatide was observed. Consistent with other incretin early response research, 18 a greater proportion of late responders were male. This finding could be related to sex differences in pharmacokinetics that result in males having lower drug exposure compared to females of the same weight. 18 Furthermore, sex hormones have been shown to play a role in body weight by regulating food intake, food reward and rate of gastric emptying. 26 Late responders also tended towards a higher baseline body weight. In addition to reducing the relative exposure to tirzepatide, other possible reasons for this slower treatment response may include higher insulin resistance with higher body weight, greater mobility limitations and higher internalized weight bias. 27 In a BMI subgroup analysis of the SURMOUNT‐1 study, higher BMI categories were associated with greater weight loss. 28 In contrast, in this analysis, we see less weight reduction in the late responder group. While a direct comparison is limited given the nature of post hoc analyses, other possible contributors in the late responder group may have attenuated the effect of higher BMI on weight reduction.
A greater proportion of late responders had hypertension. This finding in the late responders could be related to higher body weight, BMI and waist circumference, which are risk factors for hypertension. However, the reason behind this observation is unclear and raises the question for future evaluation on whether the use of antihypertensives or the underlying pathophysiology of hypertension may have attenuated their initial weight‐loss response with tirzepatide. Interestingly, a higher proportion of late responders were also non‐Hispanic or Latino. Future research is warranted to better understand the variability in weight‐loss response to tirzepatide in the Hispanic or Latino population.
Patients treated with higher tirzepatide doses (10 and 15 mg) tended to have higher percent body weight reduction, even among late responders. Late responders ultimately achieved a clinically meaningful treatment response, though to a lesser extent than early responders. The early divergence in treatment response curves suggests that the early differences between late and early responders may be informative for understanding the heterogeneity of treatment response. Factors contributing to early differences in treatment response could include individual susceptibility to side effects, underlying causes and severity of obesity and social determinants of health that influence health behaviours and treatment engagement. Future studies are warranted to better understand the variability in weight‐loss response to tirzepatide treatment.
The potential implications of the present study's findings are meaningful and could inform treatment for people living with obesity. Following current clinical treatment guidelines to discontinue treatment at 12 weeks for the late responders would have prevented most of these participants from achieving clinically meaningful weight reduction with tirzepatide. The current guidance is based on data from OMMs that have shorter titration windows and achieve lower mean treatment responses. Additionally, analyses of the treatment response pattern with those OMMs show that those who do not achieve ≥5% weight reduction at 12 weeks are unlikely to achieve that target at 52 weeks or beyond. 13
The study had several strengths. The SURMOUNT‐1 trial included a large study population that was representative of people living with obesity globally. The long duration of the trial provided adequate time to determine the weight‐loss response to tirzepatide. A limitation of the current study is that participant inclusion was limited to those who were adherent to treatment, which may not reflect adherence in the clinical setting; however, studying participants who received 75% or more of the assigned doses allowed for some dosing variation without confounding the outcomes for late responders to tirzepatide. We were unable to assess whether dietary intake or physical activity differed by responder status; however, all participants received the same standardized lifestyle intervention. While differences in adherence to these components may have influenced treatment response, this cannot be determined from the available data. Given the post hoc nature of the analysis, the p‐values are nominal and need to be interpreted by considering other clinically relevant measures. For example, baseline body weight, waist circumference and BMI were statistically significantly higher in late responders compared with early responders. Although baseline BMI categories had an insignificant p‐value, the class III obese category had a higher percentage in the late responders, corroborating the statistical significance of the anthropometric measures.
In conclusion, this post hoc analysis of SURMOUNT‐1 trial data demonstrated that the vast majority (90%) of those who had less than a 5% weight reduction by Week 12 of tirzepatide treatment ultimately had a clinically meaningful (≥5%) weight reduction by Week 72 and being on a higher dose of tirzepatide was associated with greater weight reduction, even for late responders. The average time to reach clinically meaningful weight reduction was approximately 25 weeks for the late responders. Therefore, it is reasonable to continue tirzepatide treatment for longer than 12 weeks, irrespective of the initial weight change, to be able to more fully assess the weight reduction efficacy of tirzepatide for clinical decision making and to allow additional patients to achieve clinically meaningful weight reduction.
CONFLICT OF INTEREST STATEMENT
Jamy Ard received research support from Nestle Healthcare Nutrition, Eli Lilly and Company, Boehringer Ingelheim, Epitomee, Inc., UnitedHealth Group R&D, KVKTech, WW and Novo Nordisk and is a consultant for Nestle Healthcare Nutrition, Eli Lilly and Company, Optum Labs R&D, Novo Nordisk, Intuitive, Regeneron, Brightseed, Amplifier Therapeutics, Amgen and Ingredion. Dr. Ard is an advisory board member for Novo Nordisk, Nestle Healthcare Nutrition, Eli Lilly and Company, WW and Boehringer Ingelheim. He is a member of the International Food Information Council—Assembly, The Obesity Society—President 2024, American Diabetes Association, Society of Behavioural Medicine, Roundtable on Obesity Solutions, American Society for Nutrition and American Society for Nutrition Foundation—Board of Trustees Executive Committee. Kimberly Gudzune was an Associate Professor in the Department of Medicine at the Johns Hopkins University School of Medicine and engaged in this research as a private advisor and not in her capacity as a Johns Hopkins faculty member. She received no compensation for this work. She has received personal fees for participation on advisory boards for Eli Lilly and Company and Novo Nordisk and travel support from Eli Lilly and Company and Novo Nordisk. Her former institution (Johns Hopkins) received grant funding from Novo Nordisk. Since the initial conduct of this research, Dr. Gudzune reports being an employee of the American Board of Obesity Medicine Foundation. Brandi Addison is a speaker for Eli Lilly and Company, Novo Nordisk and Corcept Therapeutics and is an advisory board member for Eli Lilly and Company. She is a member of the American Association of Clinical Endocrinology and The Obesity Society. Ildiko Lingvay received research funding (paid to institution) and/or products from Novo Nordisk, Sanofi, Boehringer‐Ingelheim, Dexcom and received research‐related consulting fees (paid to institution) from Novo Nordisk. She received advisory/consulting fees and/or other support from: AbbVie, Altimmune, Alveus Therapeutics, Amgen, Antag Therapeutics, AstraZeneca, Bayer, Betagenon AB, Bioio Inc., Biomea, Boehringer‐Ingelheim, Carmot, Cytoki Pharma, Eli Lilly and Company, Intercept, Janssen/J&J, Juvena, Keros Therapeutic, Inc., Mediflix, Merck, Metsera, Neurocrine, Novo Nordisk, Pharmaventures, Pfizer, Regeneron, Roche, Sanofi, Shionogi, Source Bio, Structure Therapeutics, TARGET RWE, TERNS Pharma, The Comm Group, WebMD and Zealand Pharma. Clare J. Lee, Dachuang Cao, Casey J. Mast, Adam Stefanski, Beverly Falcon and Donna Mojdami are employees and shareholders of Eli Lilly and Company.
PEER REVIEW
The peer review history for this article is available at https://www.webofscience.com/api/gateway/wos/peer‐review/10.1111/dom.16554.
Supporting information
Figure S1. Proportion of participants achieving weight reduction targets at Week 24 by tirzepatide dose.
Figure S2. The percent change in body weight from baseline to endpoint (Week 72) in tirzepatide 5 mg participants.
Figure S3. The percent change in body weight from baseline to endpoint (Week 72) in tirzepatide 10 mg participants.
Figure S4. The percent change in body weight from baseline to endpoint (Week 72) in tirzepatide 15 mg participants.
ACKNOWLEDGEMENTS
This study was sponsored by Eli Lilly and Company and was presented in part at the 2024 American Association of Clinical Endocrinology (AACE) meeting (9–11 May 2024).
Ard J, Lee CJ, Gudzune K, et al. Weight reduction over time in tirzepatide‐treated participants by early weight loss response: Post hoc analysis in SURMOUNT‐1. Diabetes Obes Metab. 2025;27(9):5064‐5071. doi: 10.1111/dom.16554
DATA AVAILABILITY STATEMENT
Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date for data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Figure S1. Proportion of participants achieving weight reduction targets at Week 24 by tirzepatide dose.
Figure S2. The percent change in body weight from baseline to endpoint (Week 72) in tirzepatide 5 mg participants.
Figure S3. The percent change in body weight from baseline to endpoint (Week 72) in tirzepatide 10 mg participants.
Figure S4. The percent change in body weight from baseline to endpoint (Week 72) in tirzepatide 15 mg participants.
Data Availability Statement
Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date for data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.