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Compares treatment options for Hypertension
Official title A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults
ClinicalTrials.gov ID: NCT07364175
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, being studied as a potential treatment for hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- Eligibility criteria for randomisation
- 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
You likely can't join if
- Anything in medical notes suggesting unsuitable in the opinion of the investigator Eligibility criteria for participation in weight loss arm...
- 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
See the full eligibility criteria
- Eligibility criteria for randomisation
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Cambridgeshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Cambridgeshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.