💬In plain words
What the trial is, and whether it could suit you
Hypertension is the leading risk factor for death globally, affecting approximately 30% of adults in the United Kingdom. Obesity is also a serious and ongoing epidemic, with global obesity rates having more than tripled in men and doubled in women, since 1975. In the United Kingdom, 64% of the adult population are overweight or obese. Hypertension and obesity share a well-established association, with obesity being responsible for the development of hypertension in 40-78% of cases. In young adults, this link between body size and blood pressure (BP) is much stronger that in older adults. Since overweight and obesity are among the most common and modifiable causes of high BP, weight loss induced by lifestyle-changes is recommended for overweight or obese patients with hypertension. However, lifestyle interventions, even when successful, result in only moderate weight loss, which is not ma
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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