Trial · NCT04657016
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
NCT04657016, Phase 3, Completed, Eli Lilly and Company; results first posted 2024-05-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program. Trials, record NCT04657016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04657016
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 After A Lifestyle Weight Loss Program
- NCT number
- NCT04657016
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 579 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Obesity, Overweight
- Interventions
- Tirzepatide, Placebo
- First posted
- 2020-12-07
- Last updated
- 2024-05-16
- Results first posted
- 2024-05-16
Source ClinicalTrials.gov
Registered outcomes22
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 | Baseline, 72 Weeks | Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Primary | Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction | Week 72 | Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors. |
| Secondary | Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program | 72 Weeks | Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors. |
| Secondary | Percentage of Participants Who Achieve ≥10%Body Weight Reduction | 72 Weeks | Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors. |
| Secondary | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | 72 Weeks | Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors. |
| Secondary | Percentage of Participants Who Achieve ≥20% Body Weight Reduction | 72 Weeks | Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors. |
| Secondary | Change From Baseline in Waist Circumference | Baseline, 72 Weeks | Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Secondary | Change From Baseline in Body Weight | Baseline, 72 Weeks | Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Secondary | Change From Baseline in Body Mass Index (BMI) | Baseline, 72 Weeks | Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) | Baseline, 72 Weeks | Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 | Baseline, 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction | Week 72 | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program | 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve ≥10%Body Weight Reduction | 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve ≥20% Body Weight Reduction | 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Waist Circumference | Baseline, 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | Centimeters (Cms) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight | Baseline, 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) | Baseline, 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | kilogram per meter square (kg/m^2) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) | Baseline, 72 Weeks | All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group44
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 | Placebo | 3.3 | Standard Error 0.60 | Percent change | |
| Percent Change From Baseline in Body Weight | Tirzepatide | -21.1 | Standard Error 0.59 | Percent change | |
| Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction | Placebo | 10.65 | percentage of participants | ||
| Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction | Tirzepatide | 94.37 | percentage of participants | ||
| Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program | Placebo | 37.80 | percentage of participants | ||
| Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program | Tirzepatide | 98.59 | percentage of participants | ||
| Percentage of Participants Who Achieve ≥10%Body Weight Reduction | Placebo | 4.81 | percentage of participants | ||
| Percentage of Participants Who Achieve ≥10%Body Weight Reduction | Tirzepatide | 88.03 | percentage of participants | ||
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Placebo | 2.06 | Percentage of participants | ||
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Tirzepatide | 73.94 | Percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 292 | |
| Overall Study | STARTED | Tirzepatide | 287 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo | 292 | |
| Overall Study | Received at Least One Dose of Study Drug | Tirzepatide | 287 | |
| Overall Study | COMPLETED | Placebo | 227 | |
| Overall Study | COMPLETED | Tirzepatide | 252 | |
| Overall Study | NOT COMPLETED | Placebo | 65 | |
| Overall Study | NOT COMPLETED | Tirzepatide | 35 |
Source ClinicalTrials.gov
Adverse events110
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 | 7 | 292 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Tirzepatide | 30 | 287 | 38 |
| other | Constipation | Gastrointestinal disorders | Placebo | 20 | 292 | 24 |
| other | Constipation | Gastrointestinal disorders | Tirzepatide | 66 | 287 | 89 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 27 | 292 | 53 |
| other | Diarrhoea | Gastrointestinal disorders | Tirzepatide | 89 | 287 | 233 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 9 | 292 | 10 |
| other | Dyspepsia | Gastrointestinal disorders | Tirzepatide | 27 | 287 | 47 |
| other | Eructation | Gastrointestinal disorders | Placebo | 3 | 292 | 3 |
| other | Eructation | Gastrointestinal disorders | Tirzepatide | 16 | 287 | 26 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 292 |
| Total, all-cause mortality | Tirzepatide | 1 | 287 |
| Total, other adverse events | Placebo | 172 | 292 |
| Total, other adverse events | Tirzepatide | 230 | 287 |
| Total, serious adverse events | Placebo | 14 | 292 |
| Total, serious adverse events | Tirzepatide | 17 | 287 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tirzepatide vs Placebo: deaths from any cause | Trial comparisons |
| Tirzepatide vs Placebo: serious adverse events | Trial comparisons |
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/NCT04657016
GET https://conductscience.org/api/trials/v1/NCT04657016/registered?page=2