Trial · NCT04184622
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
NCT04184622, Phase 3, Completed, Eli Lilly and Company; results first posted 2023-04-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight. Trials, record NCT04184622. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04184622
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
- NCT number
- NCT04184622
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,539 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Overweight, Obesity
- Interventions
- Tirzepatide, Placebo
- First posted
- 2019-12-03
- Last updated
- 2025-07-24
- Results first posted
- 2023-04-24
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Body Weight (Primary Treatment Period) | Baseline, Week 72 | 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. |
| Primary | Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period) | Week 72 | Percentage of participants who achieve greater than or equal to( ≥) 5% body weight reduction. |
| Secondary | Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period | Baseline, Week 20 | 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. |
| Secondary | Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period) | Week 72 | Percentage of Participants who Achieve ≥10% Body Weight Reduction |
| Secondary | Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period) | Week 72 | Percentage of participants who achieve ≥15% body weight reduction. |
| Secondary | Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period) | Week 72 | Percentage of participants who achieve ≥20% body weight reduction. |
| Secondary | Change From Baseline in Waist Circumference (Primary Treatment Period) | Baseline, Week 72 | 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. |
| Secondary | Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period | Baseline, Week 72 | 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. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. |
| Secondary | Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period | Baseline, Week 72 | Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation. |
| Secondary | Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period | Baseline, Week 72 | Results are reported as model-based estimate and SE from MMRM analysis using log transformation. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Body Weight (Primary Treatment Period) | Baseline, Week 72 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value, excluding data after prematurely stopping study drug. | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period) | Week 72 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% Body Weight Reduction, excluding data after prematurely stopping study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period | Baseline, Week 20 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 10 mg and 15 mg tirzepatide. | kilograms | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period) | Week 72 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% Body Weight Reduction, excluding data after prematurely stopping study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period) | Week 72 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥15% body weight reduction, excluding data after prematurely stopping study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period) | Week 72 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥20% Body Weight Reduction, excluding data after prematurely stopping study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Waist Circumference (Primary Treatment Period) | Baseline, Week 72 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline weight circumference value, excluding data after prematurely stopping study drug. | centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period | Baseline, Week 72 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline SF-36v2 value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 10 mg and 15 mg tirzepatide. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period | Baseline, Week 72 | All participants who received at least one dose of study drug and had a baseline and at least one post-baseline triglyceride value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period | Baseline, Week 72 | All participants who received at least one dose of study drug and had baseline and at least one post-baseline total cholesterol value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide. | percent change | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group77
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Body Weight (Primary Treatment Period) | Placebo | -2.4 | Standard Error 0.40 | percent change | |
| Percent Change From Baseline in Body Weight (Primary Treatment Period) | 5 mg Tirzepatide | -16.0 | Standard Error 0.39 | percent change | |
| Percent Change From Baseline in Body Weight (Primary Treatment Period) | 10 mg Tirzepatide | -21.4 | Standard Error 0.39 | percent change | |
| Percent Change From Baseline in Body Weight (Primary Treatment Period) | 15 mg Tirzepatide | -22.5 | Standard Error 0.39 | percent change | |
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period) | Placebo | 27.87 | Percentage of Participants | ||
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period) | 5 mg Tirzepatide | 89.41 | Percentage of Participants | ||
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period) | 10 mg Tirzepatide | 96.18 | Percentage of Participants | ||
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period) | 15 mg Tirzepatide | 96.32 | Percentage of Participants | ||
| Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period | Placebo | -2.5 | Standard Error 0.22 | kilograms | |
| Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period | Pooled 10 mg/15 mg Tirzepatide | -13.2 | Standard Error 0.16 | kilograms |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow56
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Treatment Period | STARTED | Placebo | 643 | |
| Primary Treatment Period | STARTED | 5 mg Tirzepatide | 630 | |
| Primary Treatment Period | STARTED | 10 mg Tirzepatide | 636 | |
| Primary Treatment Period | STARTED | 15 mg Tirzepatide | 630 | |
| Primary Treatment Period | Received at Least One Dose of Study Drug | Placebo | 643 | |
| Primary Treatment Period | Received at Least One Dose of Study Drug | 5 mg Tirzepatide | 630 | |
| Primary Treatment Period | Received at Least One Dose of Study Drug | 10 mg Tirzepatide | 636 | |
| Primary Treatment Period | Received at Least One Dose of Study Drug | 15 mg Tirzepatide | 630 | |
| Primary Treatment Period | Participants With Normoglycemia at Randomization | Placebo | 373 | |
| Primary Treatment Period | Participants With Normoglycemia at Randomization | 5 mg Tirzepatide | 383 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 participant flowAdverse events772
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 24 | 643 | 28 |
| other | Abdominal pain | Gastrointestinal disorders | 5 mg Tirzepatide | 38 | 630 | 52 |
| other | Abdominal pain | Gastrointestinal disorders | 10 mg Tirzepatide | 38 | 636 | 56 |
| other | Abdominal pain | Gastrointestinal disorders | 15 mg Tirzepatide | 33 | 630 | 62 |
| other | Constipation | Gastrointestinal disorders | Placebo | 38 | 643 | 49 |
| other | Constipation | Gastrointestinal disorders | 5 mg Tirzepatide | 113 | 630 | 129 |
| other | Constipation | Gastrointestinal disorders | 10 mg Tirzepatide | 117 | 636 | 148 |
| other | Constipation | Gastrointestinal disorders | 15 mg Tirzepatide | 80 | 630 | 100 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 51 | 643 | 90 |
| other | Diarrhoea | Gastrointestinal disorders | 5 mg Tirzepatide | 128 | 630 | 209 |
1 to 10 of 772Source ClinicalTrials.gov
See all 772 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 4 | 643 |
| Total, all-cause mortality | 5 mg Tirzepatide | 4 | 630 |
| Total, all-cause mortality | 10 mg Tirzepatide | 3 | 636 |
| Total, all-cause mortality | 15 mg Tirzepatide | 2 | 630 |
| Total, other adverse events | Placebo | 315 | 643 |
| Total, other adverse events | 5 mg Tirzepatide | 443 | 630 |
| Total, other adverse events | 10 mg Tirzepatide | 451 | 636 |
| Total, other adverse events | 15 mg Tirzepatide | 429 | 630 |
| Total, serious adverse events | Placebo | 53 | 643 |
| Total, serious adverse events | 5 mg Tirzepatide | 57 | 630 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers19
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04184622
GET https://conductscience.org/api/trials/v1/NCT04184622/registered?page=2