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NCT03914326 · ClinicalTrials.gov registry record · Phase 3

A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

A Phase 3 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
9,651
Enrollment target

NCT03914326: Completed Phase 3 study, sponsored by Novo Nordisk A/S.

NCT03914326 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 9,651 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1152% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03914326, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
9,651 participants
Enrollment target

Study Summary

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

Primary Outcome

Number of participants with first occurrence of EAC (event adjudication committee) confirmed major adverse cardiovascular event (MACE), a composite end-point. i.e., from time of randomization to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction and non-fatal stroke combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when par

Interventions

  • DRUG Semaglutide
  • DRUG Placebo (semaglutide)

Trial Details

FieldValue
Enrollment Target 9,651 participants
Start Date 2019-06-17
Est. Completion 2024-08-23
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT03914326 record still lists

NCT03914326 is an interventional study that assigns participants to a tested intervention. Its 9,651 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1152% higher).

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

NCT03914326 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03914326 about?

NCT03914326 is a clinical study titled "A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes". The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet wit...

What is the current status of trial NCT03914326?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 9,651 participants. The study started on 2019-06-17. Estimated completion is 2024-08-23.

What interventions are being tested in trial NCT03914326?

The interventions under investigation include: Semaglutide (DRUG), Placebo (semaglutide) (DRUG).

Who is sponsoring clinical trial NCT03914326?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03914326's enrollment target sits among peer trials

9,651 29th of 2000 higher than 1,972 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 NCT03914326, the US trial registry maintained by the National Library of Medicine. NCT03914326 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.