Standard care versus weight loss with tirzepatide for obesity-related high blood pressure in young adults
Standard of Care or Weight Loss Drug Therapy in Obesity-related Hypertension - Pilot Study
This project will test whether weight loss achieved with tirzepatide lowers blood pressure more than usual care in 18–40-year-olds who are overweight and have hypertension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT07364175 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–40 with BMI ≥27 kg/m2, a diagnosis of primary hypertension with unattended brachial SBP ≥135 and/or DBP ≥85 mmHg (and <160/100 mmHg), and who are taking no more than one antihypertensive medication.
Not a fit: Patients with secondary hypertension, those with uncontrolled or very high blood pressure (≥160/100 mmHg), a history of hypersensitivity to the study drug, or who are taking multiple antihypertensive medications are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could show that substantial weight loss with tirzepatide leads to meaningful reductions in blood pressure and may reduce the need for multiple antihypertensive drugs in young adults with obesity-related hypertension.
How similar studies have performed: GLP‑1/GIP receptor agonists including tirzepatide and related drugs have produced large, reproducible weight losses and modest blood pressure reductions in obesity trials, but using tirzepatide specifically to treat obesity-related hypertension in young adults is a newer application being tested here.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cambridge, Cambridgeshire
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.