Phase 3
Completed N=783
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
Source: ClinicalTrials.gov NCT04660643 ↗Enrolled (actual)
783
Serious AEs
2.5%
Results posted
May 2024
Primary outcomePrimary: Percent Change From Randomization in Body Weight at Week 88 — 14.8; -6.7 percent change — p=<.001
◆ Published Evidence
Established
▲ Trending
24citations · ~24 / year
Cardiometabolic Parameter Change by Weight Regain on Tirzepatide Withdrawal in Adults With Obesity: A Post Hoc Analysis of the SURMOUNT-4 Trial.
Summary
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).
Linked Publications (5)
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Cardiometabolic Parameter Change by Weight Regain on Tirzepatide Withdrawal in Adults With Obesity: A Post Hoc Analysis of the SURMOUNT-4 Trial.
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Tirzepatide Associated With Improved Health-Related Quality of Life in Adults With Obesity or Overweight in SURMOUNT-4.
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Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials.
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Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials.
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People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Randomization in Body Weight at Week 88 |
14.8; -6.7 | <.001 sig |
| SECONDARY Percent Change From Randomization in Body Weight at Week 64 |
9.9; -6.0 | <.001 sig |
| SECONDARY Change From Randomization in Body Weight |
11.9; -5.7 | <.001 sig |
| SECONDARY Change From Randomization in Waist Circumference |
8.3; -4.6 | <.001 sig |
| SECONDARY Change From Randomization in Body Mass Index (BMI) |
4.3; -2.1 | <.001 sig |
| SECONDARY Change From Randomization in Fasting Glucose |
7.74; -0.90 | <.001 sig |
| SECONDARY Change From Randomization in Hemoglobin A1c (HbA1c) |
0.25; -0.08 | <.001 sig |
| SECONDARY Percent Change From Randomization in Fasting Insulin |
23.3; -15.4 | <.001 sig |
| 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)) |
8.30; 2.29; 3.43; -3.36; 14.6; 18.3 | <.001 sig |
| SECONDARY Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) |
8.4; 2.1; 3.2; -0.4 | <.001 sig |
| SECONDARY Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score |
-1.8; 0.8 | <.001 sig |
| SECONDARY Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score |
-5.0; 4.4 | <0.001 sig |
| SECONDARY Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period |
13.50; 93.37 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline |
69.00; 98.49; 44.38; 93.98; 24.01; 87.05 | <0.001 sig |
| SECONDARY Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period |
NA; NA | <.001 sig |
| SECONDARY Change From Baseline in BMI |
-3.6; -10.0 | <.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-10.0; -27.6 | <.001 sig |
| SECONDARY Percent Change From Baseline in Body Weight |
-9.5; -26.0 | <.001 sig |
| SECONDARY Change From Baseline in Waist Circumference |
-9.1; -22.8 | <.001 sig |
| SECONDARY Change From Baseline in Fasting Glucose |
-1.72; -10.63 | <.001 sig |
| SECONDARY Change From Baseline in HbA1c |
-0.22; -0.57 | <.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Insulin |
-29.8; -54.1 | <.001 sig |
| SECONDARY Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs) |
2.16; -5.01; 2.62; -5.21; 9.44; 12.29 | <.001 sig |
| SECONDARY Change From Baseline in SBP, DBP |
-2.4; -9.3; -1.7; -5.5 | <.001 sig |
| SECONDARY Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score |
3.7; 6.3 | <.001 sig |
| SECONDARY Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score |
16.7; 26.0 | <.001 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04660643) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.