A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (SURMOUNT-4)
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| ClinicalTrials.gov Identifier: NCT04660643 |
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Recruitment Status :
Completed
First Posted : December 9, 2020
Last Update Posted : May 24, 2023
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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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 |
|---|---|---|
| Obesity Overweight | Drug: Tirzepatide Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 783 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4) |
| Actual Study Start Date : | March 29, 2021 |
| Actual Primary Completion Date : | April 25, 2023 |
| Actual Study Completion Date : | May 18, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
Drug Information available for:
Tirzepatide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC)
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Drug: Tirzepatide
Administered SC
Other Name: LY3298176 |
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Placebo Comparator: Placebo
Placebo administered SC
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Other: Placebo
Administered SC |
Primary Outcome Measures :
- Percent Change from Randomization (Week 36) in Body Weight [ Time Frame: Randomization, Week 88 ]Percent change from randomization in body weight
Secondary Outcome Measures :
- Change from Randomization in Body Weight [ Time Frame: Randomization, Week 88 ]Change from randomization in body weight
- Change from Randomization in Waist Circumference [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 88 ]Percentage of participants who achieve ≥5% body weight reduction
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Randomization, Week 64 ]Percent change from randomization in body weight
- Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, Week 88 ]Change from randomization in BMI
- Change from Randomization in Fasting Glucose [ Time Frame: Randomization, Week 88 ]Change from randomization in fasting glucose
- Change from Randomization in Hemoglobin A1c (HbA1c) [ Time Frame: Randomization, Week 88 ]Change from randomization in HbA1c
- Change from Randomization in Fasting Insulin [ Time Frame: Randomization, Week 88 ]Change from randomization in fasting insulin
- Change from Randomization in Total Cholesterol [ Time Frame: Randomization, Week 88 ]Change from randomization in total cholesterol
- Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Randomization, Week 88 ]Change from randomization in LDL cholesterol
- Change from Randomization in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Randomization, Week 88 ]Change from randomization in HDL cholesterol
- Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Randomization, Week 88 ]Change from randomization in VLDL cholesterol
- Change from Randomization in Triglycerides [ Time Frame: Randomization, Week 88 ]Change from randomization in triglycerides
- Change from Randomization in Free Fatty Acids [ Time Frame: Randomization, Week 88 ]Change from randomization in free fatty acids
- Change from Randomization in Systolic Blood Pressure (SBP) [ Time Frame: Randomization, Week 88 ]Change from randomization in SBP
- Change from Randomization in Diastolic Blood Pressure (DBP) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, Week 88 ]Change from baseline in body weight
- Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 88 ]Percent change from baseline in body weight
- Change from Baseline in BMI [ Time Frame: Baseline, Week 88 ]Change from baseline in BMI
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 88 ]Percentage of participants who achieve ≥15% body weight reduction
- Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 88 ]Change from baseline in waist circumference
- Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 88 ]Change from baseline in fasting glucose
- Change from Baseline in HbA1c [ Time Frame: Baseline, Week 88 ]Change from baseline in HbA1c
- Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 88 ]Change from baseline in fasting insulin
- Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 88 ]Change from baseline in total cholesterol
- Change from Baseline in HDL Cholesterol [ Time Frame: Baseline, Week 88 ]Change from baseline in HDL cholesterol
- Change from Baseline in LDL Cholesterol [ Time Frame: Baseline, Week 88 ]Change from baseline in LDL cholesterol
- Change from Baseline in VLDL Cholesterol [ Time Frame: Baseline, Week 88 ]Change from baseline in VLDL cholesterol
- Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 88 ]Change from baseline in triglycerides
- Change from Baseline in Free Fatty Acids [ Time Frame: Baseline, Week 88 ]Change from baseline in free fatty acids
- Change from Baseline in SBP [ Time Frame: Baseline, Week 88 ]Change from baseline in SBP
- Change from Baseline in DBP [ Time Frame: Baseline, Week 88 ]Change from baseline in DBP
- Change from Randomization in SF 36v2 Acute Form Physical Functioning Domain Score [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660643
Locations
Show 70 study locations
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 |
Additional Information:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT04660643 |
| Other Study ID Numbers: |
17247 I8F-MC-GPHN ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | December 9, 2020 Key Record Dates |
| Last Update Posted: | May 24, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | 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. |
| Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
| URL: | https://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Eli Lilly and Company:
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Metabolism and Nutrition Disorder Prediabetes |
Additional relevant MeSH terms:
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Obesity Overweight Weight Loss Overnutrition Nutrition Disorders Body Weight Body Weight Changes |
Tirzepatide Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |