SURMOUNT-4: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
Study Details
Study Description
Brief Summary
This is a study of tirzepatide in participants with obesity or overweight. The main purpose is to learn more about how tirzepatide maintains body weight loss. The study has two phases: a lead-in phase in which all participants take tirzepatide and a treatment phase in which participants will either continue tirzepatide or switch to placebo. The study will last about 2 years (25 visits).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Tirzepatide Tirzepatide administered subcutaneously (SC) |
Drug: Tirzepatide
Administered SC
Other Names:
|
Placebo Comparator: Placebo Placebo administered SC |
Other: Placebo
Administered SC
|
Outcome Measures
Primary Outcome Measures
- Percent Change from Randomization (Week 36) in Body Weight [Randomization, Week 88]
Percent change from randomization in body weight
Secondary Outcome Measures
- Change from Randomization in Body Weight [Randomization, Week 88]
Change from randomization in body weight
- Change from Randomization in Waist Circumference [Randomization, Week 88]
Change from randomization in waist circumference
- Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During the Open-Label Period [Week 88]
Percentage of participants who maintain ≥80% of the body weight lost during the open-label period
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Week 88]
Percentage of participants who achieve ≥5% body weight reduction
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Week 88]
Percentage of participants who achieve ≥10% body weight reduction
- Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% during the Open-Label Period [Randomization, Week 88]
Time to first occurrence of participants returning to >95% baseline weight for those who lost ≥5% during the open-label period
- Percent Change from Randomization in Body Weight [Randomization, Week 64]
Percent change from randomization in body weight
- Change from Randomization in Body Mass Index (BMI) [Randomization, Week 88]
Change from randomization in BMI
- Change from Randomization in Fasting Glucose [Randomization, Week 88]
Change from randomization in fasting glucose
- Change from Randomization in Hemoglobin A1c (HbA1c) [Randomization, Week 88]
Change from randomization in HbA1c
- Change from Randomization in Fasting Insulin [Randomization, Week 88]
Change from randomization in fasting insulin
- Change from Randomization in Total Cholesterol [Randomization, Week 88]
Change from randomization in total cholesterol
- Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [Randomization, Week 88]
Change from randomization in LDL cholesterol
- Change from Randomization in High Density Lipoprotein (HDL) Cholesterol [Randomization, Week 88]
Change from randomization in HDL cholesterol
- Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol [Randomization, Week 88]
Change from randomization in VLDL cholesterol
- Change from Randomization in Triglycerides [Randomization, Week 88]
Change from randomization in triglycerides
- Change from Randomization in Free Fatty Acids [Randomization, Week 88]
Change from randomization in free fatty acids
- Change from Randomization in Systolic Blood Pressure (SBP) [Randomization, Week 88]
Change from randomization in SBP
- Change from Randomization in Diastolic Blood Pressure (DBP) [Randomization, Week 88]
Change from randomization in DBP
- Change from Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form Physical Functioning Domain Score [Randomization, Week 88]
The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains; 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning 7) limitations in usual role due to emotional problems; and 8) general mental health. Domain scores are norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10, with higher scores indicating better levels of function and/or better health.
- Change from Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score [Randomization, Week 88]
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. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
- Change from Baseline in Body Weight [Baseline, Week 88]
Change from baseline in body weight
- Percent Change from Baseline in Body Weight [Baseline, Week 88]
Percent change from baseline in body weight
- Change from Baseline in BMI [Baseline, Week 88]
Change from baseline in BMI
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Week 88]
Percentage of participants who achieve ≥15% body weight reduction
- Change from Baseline in Waist Circumference [Baseline, Week 88]
Change from baseline in waist circumference
- Change from Baseline in Fasting Glucose [Baseline, Week 88]
Change from baseline in fasting glucose
- Change from Baseline in HbA1c [Baseline, Week 88]
Change from baseline in HbA1c
- Change from Baseline in Fasting Insulin [Baseline, Week 88]
Change from baseline in fasting insulin
- Change from Baseline in Total Cholesterol [Baseline, Week 88]
Change from baseline in total cholesterol
- Change from Baseline in HDL Cholesterol [Baseline, Week 88]
Change from baseline in HDL cholesterol
- Change from Baseline in LDL Cholesterol [Baseline, Week 88]
Change from baseline in LDL cholesterol
- Change from Baseline in VLDL Cholesterol [Baseline, Week 88]
Change from baseline in VLDL cholesterol
- Change from Baseline in Triglycerides [Baseline, Week 88]
Change from baseline in triglycerides
- Change from Baseline in Free Fatty Acids [Baseline, Week 88]
Change from baseline in free fatty acids
- Change from Baseline in SBP [Baseline, Week 88]
Change from baseline in SBP
- Change from Baseline in DBP [Baseline, Week 88]
Change from baseline in DBP
- Change from Randomization in SF 36v2 Acute Form Physical Functioning Domain Score [Baseline, Week 88]
The SF-36v2 acute form, 1-week recall assesses participants' HRQoL on 8 domains; 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning 7) limitations in usual role due to emotional problems; and 8) general mental health. Domain scores are norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10, with higher scores indicating better levels of function and/or better health.
- Change from Baseline in IWQOL-Lite-CT Physical Function Composite Score [Baseline, Week 88]
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. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
-
History of at least one unsuccessful dietary effort to lose body weight
Exclusion Criteria:
-
Diabetes mellitus
-
Change in body weight greater than 5 kg within 3 months prior to starting study
-
Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
-
History of pancreatitis
-
Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
-
History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
-
Any lifetime history of a suicide attempt
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cahaba Research | Pelham | Alabama | United States | 35124 |
2 | Scripps Memorial Hospital La Jolla | La Jolla | California | United States | 92037 |
3 | National Research Institute - Wilshire | Los Angeles | California | United States | 90057 |
4 | National Research Institute | Panorama City | California | United States | 91402 |
5 | Artemis Institute for Clinical Research | San Diego | California | United States | 92103 |
6 | University Clinical Investigators, Inc. | Tustin | California | United States | 92780 |
7 | New West Physicians Clinical Research | Golden | Colorado | United States | 80401 |
8 | Optumcare Colorado Springs - Monument | Monument | Colorado | United States | 80132 |
9 | Care Partners Clinical Research | Jacksonville | Florida | United States | 32277 |
10 | South Florida Clinical Research Institute | Margate | Florida | United States | 33063 |
11 | Renstar Medical Research | Ocala | Florida | United States | 34470 |
12 | ForCare Clinical Research | Tampa | Florida | United States | 33613 |
13 | Endocrine Research Solutions, Inc. | Roswell | Georgia | United States | 30076 |
14 | SKY Clinical Research Network Group-Blake | Union City | Georgia | United States | 30291 |
15 | East-West Medical Research Institute | Honolulu | Hawaii | United States | 96814 |
16 | Rocky Mountain Clinical Research | Idaho Falls | Idaho | United States | 83404 |
17 | Healthcare Research Network - Chicago | Flossmoor | Illinois | United States | 60422 |
18 | Clinical Investigation Specialists | Gurnee | Illinois | United States | 60031 |
19 | Midwest Institute For Clinical Research | Indianapolis | Indiana | United States | 46260 |
20 | American Health Network of Indiana, LLC - New Albany | New Albany | Indiana | United States | 47150 |
21 | Cotton O'Neil Clinic | Topeka | Kansas | United States | 66606 |
22 | L-MARC Research Center | Louisville | Kentucky | United States | 40213 |
23 | Centennial Medical Group | Elkridge | Maryland | United States | 21075 |
24 | MedStar Health Research Institute (MedStar Physician Based Research Network) | Hyattsville | Maryland | United States | 20782 |
25 | ActivMed Practices and Research | Methuen | Massachusetts | United States | 01844 |
26 | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | United States | 48098 |
27 | StudyMetrix Research | Saint Peters | Missouri | United States | 63303 |
28 | Glacier View Research Institute - Endocrinology | Kalispell | Montana | United States | 59901 |
29 | Weill Cornell Medical College | New York | New York | United States | 10065 |
30 | University of North Carolina Medical Center | Chapel Hill | North Carolina | United States | 27514 |
31 | PharmQuest | Greensboro | North Carolina | United States | 27408 |
32 | Wake Forest University Baptist Medical Center (WFUBMC) | Winston-Salem | North Carolina | United States | 27157 |
33 | Lillestol Research | Fargo | North Dakota | United States | 58104 |
34 | Aventiv Research Inc | Columbus | Ohio | United States | 43213 |
35 | Intend Research, LLC | Norman | Oklahoma | United States | 73069 |
36 | Summit Research Network | Portland | Oregon | United States | 97210 |
37 | Capital Area Research, LLC | Camp Hill | Pennsylvania | United States | 17011 |
38 | Tribe Clinical Research, LLC | Greenville | South Carolina | United States | 29607 |
39 | The University of Texas Health Science Center at Houston | Bellaire | Texas | United States | 77401 |
40 | Dallas Diabetes Research Center | Dallas | Texas | United States | 75230 |
41 | North Texas Endocrine Center | Dallas | Texas | United States | 75231 |
42 | Biopharma Informatic, LLC | Houston | Texas | United States | 77043 |
43 | North Hills Family Medicine/North Hills Medical Research | North Richland Hills | Texas | United States | 76180 |
44 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
45 | Northwest Houston Heart Center | Tomball | Texas | United States | 77375 |
46 | Health Research of Hampton Roads, Inc. | Newport News | Virginia | United States | 23606 |
47 | Capital Clinical Research Center | Olympia | Washington | United States | 98502 |
48 | Rainier Clinical Research Center | Renton | Washington | United States | 98057 |
49 | CEDIC | Caba | Buenos Aires | Argentina | C1060ABN |
50 | Centro Médico Viamonte | Caba | Buenos Aires | Argentina | C1120AAC |
51 | Stat Research S.A. | Ciudad Autónoma de Buenos Aire | Buenos Aires | Argentina | C1023AAB |
52 | Mautalen Salud e Investigación | Buenos Aires | Ciudad Autónoma De Buenos Aire | Argentina | C1128AAF |
53 | Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada | Ciudad Autonoma de Buenos Aire | Ciudad Autónoma De Buenos Aire | Argentina | C1425AGC |
54 | Instituto Médico Catamarca IMEC | Rosario | Santa Fe | Argentina | 2000 |
55 | Asociación de Beneficencia Hospital Sirio Libanés | Buenos Aires | Argentina | C1419AHN | |
56 | CEDOES | Vitória | Espírito Santo | Brazil | 29055450 |
57 | Cline Research Center | Curitiba | Paraná | Brazil | 80030-480 |
58 | Núcleo de Pesquisa Clínica do Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul | Brazil | 90430-001 |
59 | Centro de Pesquisa Sao Lucas | Campinas | São Paulo | Brazil | 13034-685 |
60 | BR Trials - Ensaios Clinicos e Consultoria | Sao Paulo | São Paulo | Brazil | 03325-050 |
61 | ISPEM - Instituto São José dos Campos em Pesquisas Médicas | São José dos Campos | São Paulo | Brazil | 12243-280 |
62 | IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | Brazil | 22241-180 | |
63 | CPQuali Pesquisa Clínica | São Paulo | Brazil | 01228-000 | |
64 | Centro de Endocrinologia Alcantara Gonzalez | Bayamon | Puerto Rico | 00959 | |
65 | Private Practice Dr. Martha Gomez Cuellar | San Juan | Puerto Rico | 00921 | |
66 | Wellness clinical Research Vega Baja | Vega Baja | Puerto Rico | 00694 | |
67 | Chung Shan Medical University Hospital | Taichung | Taiwan | 402 | |
68 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
69 | National Cheng-Kung Uni. Hosp. | Tainan | Taiwan | 704 | |
70 | National Taiwan University Hospital | Taipei | Taiwan | 10002 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17247
- I8F-MC-GPHN