DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies
Starting soon · Phase 4
Conditions studied: Cardiovascular Diseases
In brief
What is the research question? Semaglutide and tirzepatide cause weight loss and blood pressure reduction. However, weight loss only partially explains the blood pressure reduction. Based on previous studies, there might be direct effects in the cardiovascular system. In forearm blood flow studies, semaglutide and tirzepatide will be infused into the brachial artery to investigate their effects on the function of blood vessels. In systemic studies, semaglutide and tirzepatide will be infused into systemic circulation to investigate their effects on heart and blood vessels. There are three different populations being looked at for this study: participants with normal weight and normal blood pressure, participants with obesity and normal blood pressure, and participants with obesity and high blood pressure. There are six sub-studies each with different visit schedules. The minimum participant study duration (including follow-up phone call) would be 2 days, while the maximum participant study duration would be approximately 2 - 2.5 months. The overall study duration is expected to be approximately 18 months.
Key facts
- Study ID
- NCT07483801
- Run by
- Cambridge University Hospitals NHS Foundation Trust
- People needed
- 112
- Starts
- 2026-03-01
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-03-19
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- 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
- 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
You may not qualify if…
- 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
Where it is running
- Addenbrooke's Hospital — Cambridge, Cambridgeshire, United Kingdom
Full record on ClinicalTrials.gov
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