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DECODE

Not yet recruitingPhase 4

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

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Assets

GLP-1 / incretin class catch-all / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

112

estimated

Study population

Healthy volunteers, Hypertension, Obesity / overweight

Key I/E criterion

•BMI 18.5-24.9

Primary endpoints

•Sub-study 1A:Change in forearm blood flow parameters after infusion•Sub-study 1A•Sub-study 1B

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07483801

Org study IDDECODE (A097165)

Timeline

Milestones

Study first posted2026-03-19actual

Last update posted2026-03-19actual

Study start2026-03estimated (month precision)

Primary completion2027-04estimated (month precision)

Study completion2028-04estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide Tirzepatide

Study populations

Who this study enrolls

Healthy volunteersHypertensionObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Other (unclassified)