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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
Phase 3 trial testing Tirzepatide in Obesity in 783 participants. Completed in 18 May 2023.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 783 |
| Start date | 29 March 2021 |
| Primary completion | 25 April 2023 |
| Estimated completion | 18 May 2023 |
| Sites | 70 locations across Taiwan, Argentina, Puerto Rico, United States, Brazil |
Eli Lilly and Company — full company profile →
18 and older, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Least square (LS) mean was analysed by mixed model repeated measures (MMRM) model with randomization + analysis country + sex + interactive web response system (IWRS) MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 14.8 | ± 0.53 |
| Tirzepatide MTD | -6.7 | ± 0.52 |
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 9.9 | ± 0.38 |
| Tirzepatide MTD | -6.0 | ± 0.37 |
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 11.9 | ± 0.43 |
| Tirzepatide MTD | -5.7 | ± 0.42 |
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 8.3 | ± 0.44 |
| Tirzepatide MTD | -4.6 | ± 0.43 |
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 4.3 | ± 0.16 |
| Tirzepatide MTD | -2.1 | ± 0.15 |
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 7.74 | ± 0.548 |
| Tirzepatide MTD | -0.90 | ± 0.528 |
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.25 | ± 0.017 |
| Tirzepatide MTD | -0.08 | ± 0.017 |
LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 23.3 | ± 4.37 |
| Tirzepatide MTD | -15.4 | ± 2.88 |
LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 8.30 | ± 0.943 |
| Tirzepatide MTD | 2.29 | ± 0.852 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 3.43 | ± 1.368 |
| Tirzepatide MTD | -3.36 | ± 1.218 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 14.6 | ± 1.06 |
| Tirzepatide MTD | 18.3 | ± 1.05 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 14.7 | ± 2.32 |
| Tirzepatide MTD | -7.8 | ± 1.77 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 15.6 | ± 2.39 |
| Tirzepatide MTD | -8.2 | ± 1.81 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -2.9 | ± 2.98 |
| Tirzepatide MTD | -13.4 | ± 2.54 |
LS mean change was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (\< 10%, \>= 10%) + treatment + time + treatment\*time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 8.4 | ± 0.64 |
| Tirzepatide MTD | 2.1 | ± 0.61 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 3.2 | ± 0.44 |
| Tirzepatide MTD | -0.4 | ± 0.42 |
The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 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" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was analysed by a
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.8 | ± 0.32 |
| Tirzepatide MTD | 0.8 | ± 0.31 |
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. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher sco
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -5.0 | ± 0.95 |
| Tirzepatide MTD | 4.4 | ± 0.91 |
Time frame: Week 0 to 36 for the open-label lead-in period arm, Week 36 to 92 for the double-blind study period arms.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tirzepatide (lead-in) | Placebo | Tirzepatide MTD |
|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — |
| Cellulitis | Infections and infestations | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Atrioventricular block | Cardiac disorders | — | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — | — |
| Supraventricular tachycardia | Cardiac disorders | — | — | — |
| Goitre | Endocrine disorders | — | — | — |
| Visual impairment | Eye disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Peptic ulcer | Gastrointestinal disorders | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Covid-19 | Infections and infestations | — | — | — |
| Covid-19 pneumonia | Infections and infestations | — | — | — |
| Hepatitis viral | Infections and infestations | — | — | — |
| Peritonitis | Infections and infestations | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Clavicle fracture | Injury, poisoning and procedural complications | — | — | — |
| Lipase increased | Investigations | — | — | — |
| Malnutrition | Metabolism and nutrition disorders | — | — | — |
| Reaction | System | Tirzepatide (lead-in) | Placebo | Tirzepatide MTD |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Covid-19 | Infections and infestations | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — |
| Injection site reaction | General disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
Most-reported serious reactions: Cholecystitis acute, Cholelithiasis, Cellulitis, Osteoarthritis, Acute myocardial infarction, Atrial fibrillation, Atrioventricular block, Cardiac failure congestive.
Data from ClinicalTrials.gov NCT04660643 adverse events section.
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).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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