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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPHN | Other Identifier | Eli Lilly and Company |
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This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide (lead-in) | Experimental | Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg. |
|
| Tirzepatide MTD | Experimental | Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks. |
|
| Placebo | Placebo Comparator | Participants received weekly doses of placebo SC for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Randomization in Body Weight at Week 88 | Least square (LS) mean was analysed by mixed model repeated measures (MMRM) model with randomization + analysis country + sex + interactive web response system (IWRS) MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Randomization in Body Weight at Week 64 | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 64 |
| Change From Randomization in Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Research | Pelham | Alabama | 35124 | United States | ||
| Scripps Memorial Hospital La Jolla |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41885866 | Derived | Galindo RJ, Gudzune KA, Look M, Lee CJ, Benabbad I, Cao D, Meng Q, Mojdami D. Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials. JAMA Netw Open. 2026 Mar 2;9(3):e263274. doi: 10.1001/jamanetworkopen.2026.3274. | |
| 41640675 | Derived | Almandoz JP, Pickett-Blakely O, Tewksbury C, Stefanski A, Gonsahn-Bollie S, Dimitriadis GK, Murro AL, Cao D, Meng Q, Neff LM. Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials. Obes Pillars. 2026 Jan 23;17:100248. doi: 10.1016/j.obpill.2026.100248. eCollection 2026 Mar. |
| Label | URL |
|---|---|
| A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (SURMOUNT-4) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tirzepatide (lead-in) | Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Lead-in Period (Week 0 - 36) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2020 | Feb 1, 2024 |
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| Placebo | Other | Administered SC |
|
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables. |
| Randomization (Week 36), Week 88 |
| Change From Randomization in Waist Circumference | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Change From Randomization in Body Mass Index (BMI) | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Change From Randomization in Fasting Glucose | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Change From Randomization in Hemoglobin A1c (HbA1c) | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Percent Change From Randomization in Fasting Insulin | LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Percent Change From Randomization in Lipid Parameters (Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Very Low Density Lipoprotein (VLDL) Cholesterol, Triglycerides, Free Fatty Acids (FFA)) | LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) | LS mean change was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score | The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score | The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better health-related quality of life. LS mean was analysed by ANCOVA model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables. | Randomization (Week 36), Week 88 |
| Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period | Percentage of Participants Who Maintain at least 80% of the Body Weight Lost During the Open-Label Lead-In Period was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment*Time as variables. | Week 88 |
| Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline | Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction from baseline was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment*Time as variables. | Baseline (Week 0) to Week 88 |
| Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period | Time to first occurrence of participants returning to >95% baseline weight for those who lost ≥5% during the open-label lead-in period. | Randomization (Week 36) to Week 88 |
| Change From Baseline in BMI | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + BMI at randomization (kg/m^2) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Change From Baseline in Body Weight | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Percent Change From Baseline in Body Weight | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Change From Baseline in Waist Circumference | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Change From Baseline in Fasting Glucose | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Change From Baseline in HbA1c | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Percent Change From Baseline in Fasting Insulin | LS mean was analysed by MMRM model with log(actual measurement/baseline) = log (baseline) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs) | LS mean was analysed by MMRM model with log(actual measurement/baseline) = log (baseline) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Change From Baseline in SBP, DBP | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score | The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score | The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better health-related quality of life. LS mean was analysed by ANCOVA model with baseline + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables. | Baseline (Week 0), Week 88 |
| La Jolla |
| California |
| 92037 |
| United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| National Research Institute | Panorama City | California | 91402 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| New West Physicians Clinical Research | Golden | Colorado | 80401 | United States |
| Optumcare Colorado Springs - Monument | Monument | Colorado | 80132 | United States |
| Care Partners Clinical Research | Jacksonville | Florida | 32277 | United States |
| South Florida Clinical Research Institute | Margate | Florida | 33063 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | United States |
| SKY Clinical Research Network Group-Blake | Union City | Georgia | 30291 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Healthcare Research Network - Chicago | Flossmoor | Illinois | 60422 | United States |
| Clinical Investigation Specialists | Gurnee | Illinois | 60031 | United States |
| Midwest Institute For Clinical Research | Indianapolis | Indiana | 46260 | United States |
| American Health Network of Indiana, LLC - New Albany | New Albany | Indiana | 47150 | United States |
| Cotton O'Neil Clinic | Topeka | Kansas | 66606 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Centennial Medical Group | Elkridge | Maryland | 21075 | United States |
| MedStar Health Research Institute (MedStar Physician Based Research Network) | Hyattsville | Maryland | 20782 | United States |
| ActivMed Practices and Research | Methuen | Massachusetts | 01844 | United States |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Glacier View Research Institute - Endocrinology | Kalispell | Montana | 59901 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27514 | United States |
| PharmQuest | Greensboro | North Carolina | 27408 | United States |
| Wake Forest University Baptist Medical Center (WFUBMC) | Winston-Salem | North Carolina | 27157 | United States |
| Lillestol Research | Fargo | North Dakota | 58104 | United States |
| Aventiv Research Inc | Columbus | Ohio | 43213 | United States |
| Intend Research, LLC | Norman | Oklahoma | 73069 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Capital Area Research, LLC | Camp Hill | Pennsylvania | 17011 | United States |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | United States |
| The University of Texas Health Science Center at Houston | Bellaire | Texas | 77401 | United States |
| Dallas Diabetes Research Center | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | United States |
| North Hills Family Medicine/North Hills Medical Research | North Richland Hills | Texas | 76180 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Northwest Houston Heart Center | Tomball | Texas | 77375 | United States |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | United States |
| Capital Clinical Research Center | Olympia | Washington | 98502 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| CEDIC | CABA | Buenos Aires | C1060ABN | Argentina |
| Centro Médico Viamonte | CABA | Buenos Aires | C1120AAC | Argentina |
| Stat Research S.A. | Ciudad Autónoma de Buenos Aire | Buenos Aires | C1023AAB | Argentina |
| Mautalen Salud e Investigación | Buenos Aires | Ciudad Autónoma de Buenos Aire | C1128AAF | Argentina |
| Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada | Ciudad Autonoma de Buenos Aire | Ciudad Autónoma de Buenos Aire | C1425AGC | Argentina |
| Instituto Médico Catamarca IMEC | Rosario | Santa Fe Province | 2000 | Argentina |
| Asociación de Beneficencia Hospital Sirio Libanés | Buenos Aires | C1419AHN | Argentina |
| CEDOES | Vitória | Espírito Santo | 29055450 | Brazil |
| Cline Research Center | Curitiba | Paraná | 80030-480 | Brazil |
| Núcleo de Pesquisa Clínica do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Centro de Pesquisa Sao Lucas | Campinas | São Paulo | 13034-685 | Brazil |
| ISPEM - Instituto São José dos Campos em Pesquisas Médicas | São José dos Campos | São Paulo | 12243-280 | Brazil |
| BR Trials - Ensaios Clinicos e Consultoria | São Paulo | São Paulo | 03325-050 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | 22241-180 | Brazil |
| CPQuali Pesquisa Clínica | São Paulo | 01228-000 | Brazil |
| Centro de Endocrinologia Alcantara Gonzalez | Bayamón | 00959 | Puerto Rico |
| Private Practice Dr. Martha Gomez Cuellar | San Juan | 00921 | Puerto Rico |
| Wellness clinical Research Vega Baja | Vega Baja | 00694 | Puerto Rico |
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Cheng-Kung Uni. Hosp. | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| 41284285 | Derived | Horn DB, Linetzky B, Davies MJ, Laffin LJ, Wang H, Murphy MA, Zimner-Rapuch S, Lau E, Arad AD, Lee CJ. Cardiometabolic Parameter Change by Weight Regain on Tirzepatide Withdrawal in Adults With Obesity: A Post Hoc Analysis of the SURMOUNT-4 Trial. JAMA Intern Med. 2026 Feb 1;186(2):157-167. doi: 10.1001/jamainternmed.2025.6112. |
| 41187013 | Derived | Li X, Cao D, Sapin H, Wang F, Hunter Gibble T, Raibulet NK, Denning M, Kaplan LM. People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment. Obesity (Silver Spring). 2026 Jan;34(1):114-126. doi: 10.1002/oby.70067. Epub 2025 Nov 4. |
| 40903801 | Derived | Gibble TH, Cao D, Murphy M, Jouravskaya I, Liao B, Bays HE. Tirzepatide Associated With Improved Health-Related Quality of Life in Adults With Obesity or Overweight in SURMOUNT-4. Obesity (Silver Spring). 2025 Nov;33(11):2076-2092. doi: 10.1002/oby.70011. Epub 2025 Sep 3. |
| 40717199 | Derived | Gourgari E, Srivastava G, Kelly AS, Mojdami D, Cao D, Murphy MA, Karanikas CA, Lee CJ. Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials. Obesity (Silver Spring). 2025 Sep;33(9):1668-1679. doi: 10.1002/oby.24348. Epub 2025 Jul 27. |
| 39800653 | Derived | Horn DB, Kahan S, Batterham RL, Cao D, Lee CJ, Murphy M, Gonsahn-Bollie S, Chigutsa F, Stefanski A, Dunn JP. Time to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials. Clin Obes. 2025 Jun;15(3):e12734. doi: 10.1111/cob.12734. Epub 2025 Jan 12. |
| 38078870 | Derived | Aronne LJ, Sattar N, Horn DB, Bays HE, Wharton S, Lin WY, Ahmad NN, Zhang S, Liao R, Bunck MC, Jouravskaya I, Murphy MA; SURMOUNT-4 Investigators. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. 2024 Jan 2;331(1):38-48. doi: 10.1001/jama.2023.24945. |
Participants received weekly doses of placebo SC for 52 weeks. |
| FG002 | Tirzepatide MTD | Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks. |
| Received at Least 1 Dose of Study Drug |
|
| Completed 36-weeks of Treatment (i.e., Reaching and Tolerating the MTD at Week 36) | Eligible for randomization. |
|
| COMPLETED | All enrolled participants with a non-missing body weight measurement at week 36, regardless of treatment discontinuation were considered as lead-in period completers. |
|
| NOT COMPLETED |
|
|
| Double-blind Study Period (Week 36 - 92) |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received weekly doses of placebo SC for 52 weeks. |
| BG001 | Tirzepatide MTD | Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Body weight | Mean | Standard Deviation | kilogram (kg) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent Change From Randomization in Body Weight at Week 88 | Least square (LS) mean was analysed by mixed model repeated measures (MMRM) model with randomization + analysis country + sex + interactive web response system (IWRS) MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percent change | Randomization (Week 36), Week 88 |
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| Secondary | Percent Change From Randomization in Body Weight at Week 64 | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percent change | Randomization (Week 36), Week 64 |
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| Secondary | Change From Randomization in Body Weight | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Randomization (Week 36), Week 88 |
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| Secondary | Change From Randomization in Waist Circumference | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | centimetre (cm) | Randomization (Week 36), Week 88 |
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| Secondary | Change From Randomization in Body Mass Index (BMI) | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | kilogram per square metre (kg/m^2) | Randomization (Week 36), Week 88 |
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| Secondary | Change From Randomization in Fasting Glucose | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Randomization (Week 36), Week 88 |
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| Secondary | Change From Randomization in Hemoglobin A1c (HbA1c) | LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Randomization (Week 36), Week 88 |
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| Secondary | Percent Change From Randomization in Fasting Insulin | LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percent change | Randomization (Week 36), Week 88 |
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| Secondary | Percent Change From Randomization in Lipid Parameters (Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Very Low Density Lipoprotein (VLDL) Cholesterol, Triglycerides, Free Fatty Acids (FFA)) | LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for the respective lipid parameters, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percent change | Randomization (Week 36), Week 88 |
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| Secondary | Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) | LS mean change was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | millimetre of mercury (mmHg) | Randomization (Week 36), Week 88 |
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| Secondary | Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score | The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | T-score | Randomization (Week 36), Week 88 |
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| Secondary | Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score | The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better health-related quality of life. LS mean was analysed by ANCOVA model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Randomization (Week 36), Week 88 |
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| Secondary | Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period | Percentage of Participants Who Maintain at least 80% of the Body Weight Lost During the Open-Label Lead-In Period was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment*Time as variables. | All randomized participants who received at least one dose of the study drug, had weight loss in the open label lead-in period and at least one post-randomization value for this outcome, excluding data after discontinuation of the study drug. | Posted | Number | percentage of participants | Week 88 |
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| Secondary | Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline | Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction from baseline was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment*Time as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug. | Posted | Number | percentage of participants | Baseline (Week 0) to Week 88 |
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| Secondary | Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period | Time to first occurrence of participants returning to >95% baseline weight for those who lost ≥5% during the open-label lead-in period. | All randomized participants who received at least one dose of the study drug, lost >=5% of their weight in the open label period, excluding data after discontinuation of study drug. | Posted | Median | 95% Confidence Interval | weeks | Randomization (Week 36) to Week 88 |
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| Secondary | Change From Baseline in BMI | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + BMI at randomization (kg/m^2) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | kg/m^2 | Baseline (Week 0), Week 88 |
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| Secondary | Change From Baseline in Body Weight | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | kg | Baseline (Week 0), Week 88 |
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| Secondary | Percent Change From Baseline in Body Weight | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline (Week 0), Week 88 |
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| Secondary | Change From Baseline in Waist Circumference | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | cm | Baseline (Week 0), Week 88 |
|
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| Secondary | Change From Baseline in Fasting Glucose | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline (Week 0), Week 88 |
|
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| Secondary | Change From Baseline in HbA1c | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline (Week 0), Week 88 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Fasting Insulin | LS mean was analysed by MMRM model with log(actual measurement/baseline) = log (baseline) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline (Week 0), Week 88 |
|
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| Secondary | Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs) | LS mean was analysed by MMRM model with log(actual measurement/baseline) = log (baseline) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for the respective lipid parameters, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline (Week 0), Week 88 |
|
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| Secondary | Change From Baseline in SBP, DBP | LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (Week 0), Week 88 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score | The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | T-score | Baseline (Week 0), Week 88 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score | The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better health-related quality of life. LS mean was analysed by ANCOVA model with baseline + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Week 0), Week 88 |
|
Week 0 to 36 for the open-label lead-in period arm, Week 36 to 92 for the double-blind study period arms.
All participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of dose.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tirzepatide (lead-in) | Participants received weekly doses of tirzepatide SC for 36 weeks, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks, as tolerated, up to the MTD of either 10 mg or 15 mg. | 1 | 782 | 16 | 782 | 559 | 782 |
| EG001 | Placebo | Participants received weekly doses of placebo SC for 52 weeks. | 1 | 335 | 10 | 335 | 100 | 335 |
| EG002 | Tirzepatide MTD | Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks. | 1 | 335 | 10 | 335 | 124 | 335 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Non-hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour perforation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 26.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2023 | Feb 1, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009748 | Nutrition Disorders |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
Not provided
Not provided
| Pregnancy |
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| Withdrawal by Subject |
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| Protocol deviation |
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| Other - as reported by the investigator |
|
| Perceived excessive weight loss |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
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| Unknown or Not Reported |
|
| Brazil |
|
| Taiwan |
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| United States |
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| Participants |
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