Trial · NCT05822830
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
NCT05822830, Phase 3, Completed, Eli Lilly and Company; results first posted 2025-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities. Trials, record NCT05822830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05822830
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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 With Weight Related Comorbidities
- NCT number
- NCT05822830
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 751 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Obesity, Overweight
- Interventions
- Tirzepatide, Semaglutide
- First posted
- 2023-04-21
- Last updated
- 2025-11-26
- Results first posted
- 2025-11-26
Source ClinicalTrials.gov
Registered outcomes9
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, Week 72 | Percent change from baseline in body weight was reported. Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables. |
| Secondary | Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Week 72 | Percentage of participants who achieved ≥10% body weight reduction (observed values) was reported. |
| Secondary | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Week 72 | Percentage of participants who achieved ≥15% body weight reduction (observed values) was reported. |
| Secondary | Percentage of Participants Who Achieve ≥20% Body Weight Reduction | Week 72 | Percentage of participants who achieved ≥20% body weight reduction (observed values) was reported. |
| Secondary | Percentage of Participants Who Achieve ≥25% Body Weight Reduction | Week 72 | Percentage of participants who achieved ≥25% body weight reduction (observed values) was reported. |
| Secondary | Change From Baseline in Waist Circumference in Centimeter | Baseline, Week 72 | Change from baseline in waist circumference in centimeter was reported. LS mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables. |
| Secondary | Percentage of Participants Who Achieve ≥30% Body Weight Reduction | Week 72 | Percentage of participants who achieved ≥30% body weight reduction (observed values) was reported. |
| Secondary | Change From Baseline in Body Mass Index (BMI) | Baseline, Week 72 | Change from baseline in BMI was reported. LS mean was determined using Mixed Model Repeated Measures (MMRM) model using Baseline + Sex + Pre diabetes status at randomization + Treatment + Time + Treatment\*Time(Type III sum of squares) as variables. |
| Secondary | Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide | Baseline, Week 72 | Percent change from baseline in body weight comparing 15mg of Tirzepatide and 2.4 mg Semaglutide was reported. The treatment effect for tirzepatide versus semaglutide for percent change in body weight was also evaluated assuming that participants had stayed on treatment and reached the highest dose of treatment. LS mean was determined by MMRM model using Baseline + Sex + Pre diabetes status at randomization + Baseline BMI Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
Source ClinicalTrials.gov
Outcomes9
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, Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve ≥20% Body Weight Reduction | Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve ≥25% Body Weight Reduction | Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Waist Circumference in Centimeter | Baseline, Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieve ≥30% Body Weight Reduction | Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) | Baseline, Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | kilograms per meter square | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide | Baseline, Week 72 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
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 | 15 mg or MTD - Tirzepatide | -20.2 | Standard Error 0.59 | Percent change | |
| Percent Change From Baseline in Body Weight | 2.4 mg or MTD - Semaglutide | -13.7 | Standard Error 0.59 | Percent change | |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | 15 mg or MTD - Tirzepatide | 87.7 | Percentage of participants | ||
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | 2.4 mg or MTD - Semaglutide | 66.7 | Percentage of participants | ||
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | 15 mg or MTD - Tirzepatide | 71.7 | Percentage of participants | ||
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | 2.4 mg or MTD - Semaglutide | 45.0 | Percentage of participants | ||
| Percentage of Participants Who Achieve ≥20% Body Weight Reduction | 15 mg or MTD - Tirzepatide | 55.0 | Percentage of participants | ||
| Percentage of Participants Who Achieve ≥20% Body Weight Reduction | 2.4 mg or MTD - Semaglutide | 31.1 | Percentage of participants | ||
| Percentage of Participants Who Achieve ≥25% Body Weight Reduction | 15 mg or MTD - Tirzepatide | 36.5 | Percentage of participants | ||
| Percentage of Participants Who Achieve ≥25% Body Weight Reduction | 2.4 mg or MTD - Semaglutide | 18.6 | Percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 15 mg or MTD - Tirzepatide | 375 | |
| Overall Study | STARTED | 2.4 mg or MTD - Semaglutide | 376 | |
| Overall Study | Received At Least One Dose of Study Drug | 15 mg or MTD - Tirzepatide | 374 | |
| Overall Study | Received At Least One Dose of Study Drug | 2.4 mg or MTD - Semaglutide | 376 | |
| Overall Study | COMPLETED | 15 mg or MTD - Tirzepatide | 319 | |
| Overall Study | COMPLETED | 2.4 mg or MTD - Semaglutide | 319 | |
| Overall Study | NOT COMPLETED | 15 mg or MTD - Tirzepatide | 56 | |
| Overall Study | NOT COMPLETED | 2.4 mg or MTD - Semaglutide | 57 |
Source ClinicalTrials.gov
Adverse events96
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 distension | Gastrointestinal disorders | 15 mg or MTD - Tirzepatide | 27 | 374 | 50 |
| other | Abdominal distension | Gastrointestinal disorders | 2.4 mg or MTD - Semaglutide | 24 | 376 | 29 |
| other | Abdominal pain | Gastrointestinal disorders | 15 mg or MTD - Tirzepatide | 24 | 374 | 31 |
| other | Abdominal pain | Gastrointestinal disorders | 2.4 mg or MTD - Semaglutide | 26 | 376 | 29 |
| other | Constipation | Gastrointestinal disorders | 15 mg or MTD - Tirzepatide | 101 | 374 | 179 |
| other | Constipation | Gastrointestinal disorders | 2.4 mg or MTD - Semaglutide | 107 | 376 | 167 |
| other | Diarrhoea | Gastrointestinal disorders | 15 mg or MTD - Tirzepatide | 88 | 374 | 227 |
| other | Diarrhoea | Gastrointestinal disorders | 2.4 mg or MTD - Semaglutide | 88 | 376 | 212 |
| other | Dyspepsia | Gastrointestinal disorders | 15 mg or MTD - Tirzepatide | 22 | 374 | 31 |
| other | Dyspepsia | Gastrointestinal disorders | 2.4 mg or MTD - Semaglutide | 28 | 376 | 40 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 15 mg or MTD - Tirzepatide | 0 | 374 |
| Total, all-cause mortality | 2.4 mg or MTD - Semaglutide | 0 | 376 |
| Total, other adverse events | 15 mg or MTD - Tirzepatide | 255 | 374 |
| Total, other adverse events | 2.4 mg or MTD - Semaglutide | 267 | 376 |
| Total, serious adverse events | 15 mg or MTD - Tirzepatide | 18 | 374 |
| Total, serious adverse events | 2.4 mg or MTD - Semaglutide | 13 | 376 |
Source ClinicalTrials.gov
Papers4
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 |
|---|---|
| 15 mg or MTD - Tirzepatide vs 2.4 mg or MTD - Semaglutide: deaths from any cause | Trial comparisons |
| 15 mg or MTD - Tirzepatide vs 2.4 mg or MTD - Semaglutide: 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/NCT05822830
GET https://conductscience.org/api/trials/v1/NCT05822830/events?page=2