A Study of Tirzepatide in Overweight and Very Overweight Participants

Summary

The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on appetite will also be studied. The study will last up to about four months and will include up to 14 visits to the study center.

Timeline

Start

2020-08-24

Primary completion

2022-12-16

Completion

2022-12-16

Outcome

Met primary endpoint

paper Tirzepatide reduced energy intake versus placebo at week 3 (estimated treatment difference -524.6 kcal (95% confidence interval -648.1 to -401.0), P < 0.0001). PMID 40555748 ↗

registry analysis (superiority test); Placebo vs Tirzepatide; p <.0001; Median Difference (Final Values) -534.11 (95% CI -668.20 to -400.02); ANCOVA NCT04311411 ↗

Publications

• Martin CK, Carmichael OT, Carnell S, Considine RV, Kareken DA, Dydak U, Mattes RD, Scott D, Shcherbinin S, Nishiyama H, Knights A, Urva S, Biernat L, Pratt E, Haupt A, Mintun M, Otero Svaldi D, Milicevic Z, Coskun T. Tirzepatide on ingestive behavior in adults with overweight or obesity: a randomized 6-week phase 1 trial. Nat Med. 2025 Sep;31(9):3141-3150. doi: 10.1038/s41591-025-03774-9. Epub 2025 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Liraglutide	Peptide	3 mg	Subcutaneous
Subject	Tirzepatide	Peptide	10 mg	Subcutaneous

Indications