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NCT04081337 · ClinicalTrials.gov registry record · Phase 1
A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT04081337: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT04081337 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04081337, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.
Primary Outcome
SMR was measured using whole-room indirect calorimetry (respiratory chamber). Change from Baseline to Week 18 in SMR was evaluated. Least square (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables.
Interventions
- DRUG Placebo
- DRUG Tirzepatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2022-05-26 |
| Phase | Phase 1 |
What the finished NCT04081337 record still lists
NCT04081337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04081337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04081337 about?
NCT04081337 is a clinical study titled "A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide". This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.
What is the current status of trial NCT04081337?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2020-07-09. Estimated completion is 2022-05-26.
What interventions are being tested in trial NCT04081337?
The interventions under investigation include: Placebo (DRUG), Tirzepatide (DRUG).
Who is sponsoring clinical trial NCT04081337?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04081337's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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