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NCT04560998 · ClinicalTrials.gov registry record · Phase 3
A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 792
- Enrollment target
NCT04560998: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT04560998 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 792 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04560998, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 792 participants
- Enrollment target
Study Summary
This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Primary Outcome
Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was
Interventions
- DRUG Semaglutide
- DRUG Placebo (semaglutide)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 792 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2024-07-12 |
| Phase | Phase 3 |
What the finished NCT04560998 record still lists
NCT04560998 is an interventional study that assigns participants to a tested intervention. The registered 792 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Semaglutide is the first listed.
NCT04560998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04560998 about?
NCT04560998 is a clinical study titled "A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes". This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided ...
What is the current status of trial NCT04560998?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 792 participants. The study started on 2020-10-01. Estimated completion is 2024-07-12.
What interventions are being tested in trial NCT04560998?
The interventions under investigation include: Semaglutide (DRUG), Placebo (semaglutide) (DRUG).
Who is sponsoring clinical trial NCT04560998?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04560998's enrollment target sits among peer trials
792 429th of 2000 higher than 1,572 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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