Standard care versus weight loss with tirzepatide for obesity-related high blood pressure in young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a feasibility, within-cohort randomized design comparing usual hypertension care to an intervention that aims for weight loss using tirzepatide in young adults with overweight or obesity and primary hypertension. Eligible participants are aged 18–40 with BMI ≥27 kg/m2, unattended brachial SBP ≥135 and/or DBP ≥85 mmHg but below 160/100 mmHg, and on no more than one antihypertensive medication. The trial will randomize suitable cohort members to standard care or to a weight-loss pathway that includes tirzepatide, with blood pressure and medication use monitored over time. The main goal is to determine feasibility and to gather preliminary data on whether drug-induced weight loss leads to clinically meaningful BP reductions in this population.

Why it matters

Who can join: the full rules

Eligibility criteria for randomisation

Inclusion Criteria:

* Aged 18 to 40 years (inclusive)
* Body mass index (BMI) ≥27 kg/m2
* Clinical diagnosis of primary (essential) hypertension as per NICE guidance
* Unattended brachial SBP ≥135 and/or DBP ≥85 mmHg and \<160/100 mmHg
* Maximum of one antihypertensive medication

Exclusion Criteria:

• Anything in medical notes suggesting unsuitable in the opinion of the investigator

Eligibility criteria for participation in weight loss arm

Inclusion criteria:

* Written informed consent
* Aged 18 to 40 years (inclusive)
* Body mass index ≥27 kg/m2
* Clinical diagnosis of primary (essential) hypertension as per NICE guidance
* Unattended brachial SBP ≥135 and/or DBP ≥85 mmHg and \<160/100 mmHg
* Maximum of one antihypertensive medication

Exclusion criteria:

The presence of any of the following will preclude participant inclusion:

* Known or suspected secondary hypertension
* Hypersensitivity to any of the study drugs or excipients
* Currently taking drugs likely to have interactions with tirzepatide
* 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
* Prior or planned surgical, endoscopic and/or device-based therapy treatment for obesity
* Self-reported, intentional or unintentional, change in body weight (over \~10%) within \~three months of screening
* Known heart failure or clinically significant valvular heart disease
* Implanted pacemaker or implantable cardioverter defibrillator (ICD)
* Second or third-degree AV block, sino-atrial block, sick sinus syndrome
* Known active malignancy including thyroid cancer
* Known renal impairment (creatinine \>150µmol/L)
* Clinically significant neurological disease
* History of scleroderma
* Participants on anticoagulant therapy
* Known history of pancreatitis
* Known inflammatory bowel disease
* History of gallstones (unless previous cholecystectomy)
* Severe gastroparesis or gastric emptying abnormality
* Family history of multiple endocrine neoplasia
* Needle-phobia
* Planned pregnancy, current pregnancy, or breastfeeding
* Current involvement in the active treatment phase of other research studies
* Any other clinical reason which may preclude entry in the opinion of the investigator

Where it's running

• Cambridge University Hospitals NHS Foundation Trust
  Cambridge, Cambridgeshire, United Kingdom Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.