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

Sponsor
Cambridge University Hospitals NHS Foundation Trust
Study ID
NCT07483801
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Semaglutide: GLP-1 analogue
  • Tirzepatide — DRUG
    Tirzepatide: dual GIP/GLP-1 receptor agonist

Study Details

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 Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Sub-study 1A
    Intra-arterial infusion of semaglutide
  • Experimental: Sub-study 1B
    Intra-arterial infusion of Tirzepatide
  • Experimental: Sub-study 1C
    Intra-arterial infusion of Saline, Semaglutide and Tirzepatide
  • Experimental: Sub-study 2A
    Slow intravenous bolus of Semaglutide
  • Experimental: Sub-study 2B
    Slow intravenous bolus of Tirzepatide
  • Experimental: Sub-study 2C
    Slow intravenous bolus of Semaglutide and Tirzepatide

Primary Outcome Measure

Sub-study 1A:Change in forearm blood flow parameters after infusion of semaglutide (Ratio) [ Time Frame: 2-2.5 months from screening to follow-up ]

Central Contacts

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