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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
Phase 3 trial testing Tirzepatide in Overweight in 2,539 participants. Completed in 6 July 2024.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 2,539 |
| Start date | 4 December 2019 |
| Primary completion | 1 April 2022 |
| Estimated completion | 6 July 2024 |
| Sites | 118 locations across Japan, Russia, Taiwan, Mexico, Argentina, Puerto Rico, China, United States |
Eli Lilly and Company — full company profile →
18 and older, any sex, with Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -2.4 | ± 0.40 |
| 5 mg Tirzepatide | -16.0 | ± 0.39 |
| 10 mg Tirzepatide | -21.4 | ± 0.39 |
| 15 mg Tirzepatide | -22.5 | ± 0.39 |
Percentage of participants who achieve greater than or equal to( ≥) 5% body weight reduction.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 27.87 | |
| 5 mg Tirzepatide | 89.41 | |
| 10 mg Tirzepatide | 96.18 | |
| 15 mg Tirzepatide | 96.32 |
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -2.5 | ± 0.22 |
| Pooled 10 mg/15 mg Tirzepatide | -13.2 | ± 0.16 |
Percentage of Participants who Achieve ≥10% Body Weight Reduction
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 13.54 | |
| 5 mg Tirzepatide | 73.35 | |
| 10 mg Tirzepatide | 85.85 | |
| 15 mg Tirzepatide | 90.08 |
Percentage of participants who achieve ≥15% body weight reduction.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 5.98 | |
| 5 mg Tirzepatide | 50.24 | |
| 10 mg Tirzepatide | 73.61 | |
| 15 mg Tirzepatide | 78.24 |
Percentage of participants who achieve ≥20% body weight reduction.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.26 | |
| 5 mg Tirzepatide | 31.62 | |
| 10 mg Tirzepatide | 55.48 | |
| 15 mg Tirzepatide | 62.88 |
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -3.4 | ± 0.42 |
| 5 mg Tirzepatide | -14.6 | ± 0.41 |
| 10 mg Tirzepatide | -19.4 | ± 0.41 |
| 15 mg Tirzepatide | -19.9 | ± 0.41 |
The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.7 | ± 0.27 |
| Pooled 10 mg/15 mg Tirzepatide | 4.0 | ± 0.18 |
Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -6.3 | ± 1.55 |
| Pooled 5 mg/10 mg/15 mg Tirzepatide | -27.6 | ± 0.66 |
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.11 | ± 0.695 |
| Pooled 5 mg/10 mg/15 mg Tirzepatide | -5.97 | ± 0.364 |
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.25 | ± 0.757 |
| Pooled 5 mg/10 mg/15 mg Tirzepatide | 7.92 | ± 0.447 |
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.3 | ± 0.48 |
| Pooled 5 mg/10 mg/15 mg Tirzepatide | -8.1 | ± 0.27 |
Time frame: Baseline up to Week 193. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | 5 mg Tirzepatide | 10 mg Tirzepatide | 15 mg Tirzepatide |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | — | — | — | — |
| Covid-19 pneumonia | Infections and infestations | — | — | — | — |
| Covid-19 | Infections and infestations | — | — | — | — |
| Appendicitis | Infections and infestations | — | — | — | — |
| Pancreatitis acute | Gastrointestinal disorders | — | — | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — | — | — |
| Cholecystitis chronic | Hepatobiliary disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — | — |
| Obstructive pancreatitis | Gastrointestinal disorders | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — | — | — |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Ischaemic stroke | Nervous system disorders | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Acute coronary syndrome | Cardiac disorders | — | — | — | — |
| Angina unstable | Cardiac disorders | — | — | — | — |
| Aortic valve stenosis | Cardiac disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Cardiac failure acute | Cardiac disorders | — | — | — | — |
| Coronary artery occlusion | Cardiac disorders | — | — | — | — |
| Reaction | System | Placebo | 5 mg Tirzepatide | 10 mg Tirzepatide | 15 mg Tirzepatide |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Covid-19 | Infections and infestations | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| Injection site reaction | General disorders | — | — | — | — |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | — | — | — | — |
| Eructation | Gastrointestinal disorders | — | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
Most-reported serious reactions: Cholelithiasis, Covid-19 pneumonia, Covid-19, Appendicitis, Pancreatitis acute, Cholecystitis acute, Cholecystitis chronic, Pneumonia.
Data from ClinicalTrials.gov NCT04184622 adverse events section.
This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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