Phase 3
N=938
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight
Type 2 Diabetes · Overweight · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04657003 ↗Enrolled (actual)
938
Serious AEs
7.2%
Results posted
Apr 2024
Primary outcome: Primary: Percent Change From Baseline in Body Weight — -3.3; -13.4; -15.7 percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tirzepatide (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight |
-3.3; -13.4; -15.7 | <0.001 sig |
| PRIMARY Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline |
30.55; 81.55; 86.41 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline |
8.68; 63.43; 69.58 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline |
2.57; 41.42; 51.78 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline |
0.96; 22.98; 33.98 | <0.001 sig |
| SECONDARY Change From Baseline in Absolute Body Weight |
-3.2; -13.5; -15.6 | <0.001 sig |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
-1.2; -4.9; -5.7 | <0.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.16; -2.14; -2.22 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve HbA1c <7% |
29.31; 90.03; 90.67 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve HbA1c ≤6.5% |
15.52; 84.05; 86.67 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve HbA1c <5.7% |
2.76; 50.17; 55.33 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Glucose |
-2.42; -49.20; -51.67 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference |
-3.4; -11.2; -13.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
2.13; -2.58 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
6.29; 2.72 | 0.112 |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
1.10; 8.19 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-6.0; -27.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-5.8; -28.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
2.30; -6.64 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide) |
0.03; -23.58 | <0.001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide) |
-1.0; -7.2 | <0.001 sig |
| SECONDARY Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide) |
-0.2; -2.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Insulin |
-14.5; -29.6; -40.3 | <0.001 sig |
| SECONDARY Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score |
1.6; 3.4; 3.8 | 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 |
7.4; 14.3; 15.2 | <0.001 sig |
| SECONDARY Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide |
153000; 234000 | — |
Summary
This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).
Eligibility Criteria
Inclusion Criteria
- Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
- Have a BMI of ≥27 kg/m²
- Are overweight or have obesity
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
- Are at least 18 years of age and age of majority per local laws and regulations
Exclusion Criteria
- Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
- Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
- Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
- Have self-reported change in body weight >5kg within 3 months prior to screening
- Have had a history of chronic or acute pancreatitis
- 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
- 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 (NCT04657003). 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.