Phase 3
Completed N=579
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
Source: ClinicalTrials.gov NCT04657016 ↗Enrolled (actual)
579
Serious AEs
5.4%
Results posted
May 2024
Primary outcomePrimary: Percent Change From Baseline in Body Weight — 3.3; -21.1 Percent change — p=<0.001
◆ Published Evidence
Emerging
4citations · ~4 / year
Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials.
Summary
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).
Linked Publications (5)
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Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials.
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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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Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT.
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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 Baseline in Body Weight |
3.3; -21.1 | <0.001 sig |
| PRIMARY Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction |
10.65; 94.37 | <0.001 sig |
| SECONDARY Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program |
37.80; 98.59 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥10%Body Weight Reduction |
4.81; 88.03 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥15% Body Weight Reduction |
2.06; 73.94 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥20% Body Weight Reduction |
1.03; 54.93 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference |
1.1; -16.8 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
3.5; -21.5 | <0.001 sig |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
1.2; -7.7 | <0.001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) |
4.4; -5.8 | <0.001 sig |
| SECONDARY Change From Baseline in Diastolic Blood Pressure (DBP) |
2.3; -3.4 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol |
5.19; -3.00 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol |
3.6; 15.4 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol |
6.14; -6.07 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol |
3.0; -25.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides |
3.0; -25.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Free Fatty Acids |
-15.0; -33.1 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Glucose |
2.4; -8.8 | <0.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
0.01; -0.46 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Insulin |
17.3; -39.1 | <0.001 sig |
| SECONDARY Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score |
-0.6; 3.3 | <0.001 sig |
| SECONDARY Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score |
1.1; 13.9 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or 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 (NCT04657016) 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.