Study S000078

A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04081337
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 55
Start: 2020-07-09
Primary completion: 2022-05-26
Lead sponsor: Eli Lilly and Company
Conditions: Obesity
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:I8F-MC-GPGU

Registered primary outcomes

Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR) [Baseline, Week 18]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0004227	Tirzepatide did not impact metabolic adaptation in people with obesity, but increased fat oxidation. Ravussin E, Cell metabolism	2025	Other trial	PMID 40203836 DOI	cites ClinicalTrials.gov:NCT04081337