DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to 50 Years; healthy volunteers accepted; excludes diabetes; BMI ≥30 required; non-obese participants included; conditions: Cardiovascular Diseases
- Interventions
- semaglutide; Tirzepatide
- Conditions
- Cardiovascular Diseases
- Phase and size
- Phase 4 · 112 participants
- Dates
- Start 2026-03
Primary completion 2027-04 - Sponsor
- Cambridge University Hospitals NHS Foundation Trust (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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
02Eligibility
Who can take part
Inclusion Criteria: 1. Inclusion Criteria - Participants with normal weight and normal blood pressure * Have given written informed consent to participate * Aged 18 to 50 years (inclusive) * Females must be post/peri-menopausal or if of child-bearing potential they are required to use adequate contraception and to have a negative pregnancy test (performed at each visit) * Current non-smoker * Body mass index (BMI) in range 18.5-24.9 kg/m2 * Clinic brachial systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg 2. Inclusion Criteria - Obese participants with normal blood pressure * Have given written informed consent to participate * Aged 18 to 50 years (inclusive) * Male or female * Females must be post/peri-menopausal or if of child-bearing potential they are required to use adequate contraception and to have negative pregnancy test (performed at each visit) * Current non-smoker * BMI ≥30 kg/m2 * Clinic brachial systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg 3. Inclusion Criteria - Obese participants with high blood pressure * Have given written informed consent to participate * Aged 18 to 50 years (inclusive) * Male or female * Females must be post/peri-menopausal or if of child-bearing potential they are required to use adequate contraception and to have negative pregnancy test (performed at each visit) * Current non-smoker * BMI ≥30 kg/m2 * Diagnosis of stage 1 essential hypertension Exclusion Criteria: * Regular use of medications with vasoactive or cardiac effects in normotensive individuals; inability or unwillingness to omit anti-hypertensive medications on the morning of the study visits in hypertensive individuals * Hypersensitivity to any of the study drugs or excipients * Known clinically significant valvular heart disease * Implanted pacemaker or implantable cardioverter defibrillator (ICD) * Known active malignancy * Known renal impairment (creatinine \>150µmol/L) * Clinically significant neurological disease * History of scleroderma * Current pregnancy, breastfeeding * Current involvement in the active treatment phase of other research studies (excluding observational/non-interventional) * Second or third-degree AV block, sino-atrial block, sick sinus syndrome * Known HIV, hepatitis B or C * Needle phobia * Participants treated with formal anticoagulant therapy such as, but not limited to, heparin or warfarin * Diagnosis of Type 1 or Type 2 Diabetes Mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP-1 and GIP receptor agonists * BMI \<18.5 kg/m2 * Known heart failure * Currently taking drugs likely to have interactions with semaglutide or tirzepatide * Family history of multiple endocrine neoplasia * Known thyroid cancer * Known history of pancreatitis * History of gall stones (unless the gall bladder has been removed) * Any other clinical reason which may preclude entry in the opinion of the investigator
03Change log
Registry changes
No changes recorded since the trial was added.