DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies

Registration

Registration

NCT07483801

Acronym

DECODE

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE4

Masking

DOUBLE

Status

NOT_YET_RECRUITING

Enrollment

112

Start

2026-03

Primary completion

2027-04

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Conditions

Cardiovascular Diseases

Interventions

DRUG:semaglutide; DRUG:Tirzepatide

Results posted

FALSE

Individual participant data sharing

UNDECIDED

Registered primary outcomes

• Sub-study 1A:Change in forearm blood flow parameters after infusion of semaglutide (Ratio) [2-2.5 months from screening to follow-up]
• Sub-study 1A:Change in forearm blood flow parameters after infusion of semaglutide (Absolute flow) [2-2.5 months from screening to follow-up]
• Sub-study 1A: Change in forearm blood flow parameters after infusion of semaglutide (Percentage Change) [2-2.5 months from screening to follow-up]
• Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Absolute flow) [2-2.5 months from screening to follow-up]
• Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Ratio) [2-2.5 months from screening to follow-up]
• Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Percent Change) [2-2.5 months from screening to follow-up]
• Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Absolute flow) [2-2.5 months from screening to follow-up]
• Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Ratio) [2-2.5 months from screening to follow-up]
• Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Percentage change) [2-2.5 months from screening to follow-up]
• Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Blood pressure) [2-2.5 months from screening to follow-up]
• Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Heart rate) [2-2.5 months from screening to follow-up]
• Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Cardiac output) [2-2.5 months from screening to follow-up]
• Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Vascular resistance) [2-2.5 months from screening to follow-up]
• Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Blood pressure) [2-2.5 months from screening to follow-up]
• Sub-study 2B: Changes in cardiovascular haemodynamic variables ) after administration of tirzepatide (Heart rate) [2-2.5 months from screening to follow-up]
• Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Cardiac output) [2-2.5 months from screening to follow-up]
• Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Vascular resistance) [2-2.5 months from screening to follow-up]
• Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Blood pressure) [2-2.5 months from screening to follow-up]
• Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Heart rate) [2-2.5 months from screening to follow-up]
• Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Cardiac output) [2-2.5 months from screening to follow-up]
• Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Vascular resistance) [2-2.5 months from screening to follow-up]