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NCT04657003 · ClinicalTrials.gov registry record · Phase 3

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
938
Enrollment target

NCT04657003: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT04657003 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 938 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04657003, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
938 participants
Enrollment target

Study Summary

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

Primary Outcome

Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

Interventions

  • DRUG Tirzepatide
  • OTHER Placebo

Trial Details

FieldValue
Enrollment Target 938 participants
Start Date 2021-03-29
Est. Completion 2023-04-10
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT04657003 record still lists

NCT04657003 is an interventional study that assigns participants to a tested intervention. The registered 938 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher).

The record links to 0 conditions, and to 2 interventions - of which Tirzepatide is the first listed.

NCT04657003 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04657003 about?

NCT04657003 is a clinical study titled "A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight". This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

What is the current status of trial NCT04657003?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 938 participants. The study started on 2021-03-29. Estimated completion is 2023-04-10.

What interventions are being tested in trial NCT04657003?

The interventions under investigation include: Tirzepatide (DRUG), Placebo (OTHER).

Who is sponsoring clinical trial NCT04657003?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04657003's enrollment target sits among peer trials

938 338th of 2000 higher than 1,663 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT04657003, the US trial registry maintained by the National Library of Medicine. NCT04657003 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.