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A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults

Sponsor: Cambridge University Hospitals NHS Foundation Trust

NCT ID: NCT07364175

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tirzepatide (drug), Anti-Hypertensive medications (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Tirzepatide — drug: 2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for 12 weeks · Anti-Hypertensive medications — drug: Anti-hypertensive drug therapy as per local and national guidelines
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 40 Years
Who
All
Number of participants
60
Started
2026-01
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for hypertension
  • • NA - 60 participants
  • • Hypertension is the leading risk factor for death globally, affecting approximately 30% of adults in the United Kingdom

Who can take part?

  • • Ages 18 Years to 40 Years
  • • Diagnosed with hypertension

Where?

  • • Cambridge - Cambridge University Hospitals NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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 maintained in the majority of cases. A meta-analysis of randomised controlled trials demonstrated that lifestyle-interventions lead to an average net weight reduction of 5.1 kg, accompanied by a significant, but modest, \~4 mmHg reduction in BP. Weight loss interventions could play a crucial role in the treatment of obesity-related hypertension in young adults. Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, originally developed for the treatment of type 2 diabetes, are safe and clinically effective anti-obesity drugs. Recent data show a 10-20% placebo-adjusted reduction in body weight in overweight or obese adults without diabetes using the GLP-1 analogue semaglutide or the dual GLP-1/GIP receptor agonist tirzepatide, with the majority of weight loss achieved within the initial six months. The substantial weight loss induced by these drugs is accompanied by a significant reduction in BP. Two recent meta-analyses showed that semaglutide is associated with a \~5 mmHg placebo-adjusted reduction in clinic systolic BP (SBP). A sub-study of the SURMOUNT-1 trial reported a \~10 mmHg reduction in 24-h ambulatory SBP with tirzepatide. Most participants in these studies were normotensive or had well-controlled hypertension. Furthermore, antihypertensive medication use declined amongst those receiving anti-obesity drugs meaning the BP-lowering effect of weight loss, elicited by these drugs, is probably underestimated. These data suggest that the new anti-obesity drugs could be effective in managing overweight or obesity-related hypertension. Furthermore, it may be possible to cure hypertension in at least some young adults, removing the need for life-long antihypertensive treatment. However, the magnitude and time course of BP reduction elicited by these new anti-obesity drugs remain uncertain. The primary aim of this feasibility study is to assess the extent and trajectory of BP reduction achieved through intensive weight loss in overweight or obese adults with stage 1 hypertension and compare this to current standard of care measures which uses anti-hypertensive medications and lifestyle advice. The study will utilise a modified trial within cohort approach, using patients based within the clinical pharmacology/hypertension service at Addenbrooke's Hospital, Cambridge.

HypertensionObesity & Overweight

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 40 Years
  • Who can join: All genders

What the study is looking for

  • ✓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

Who cannot take part

  • ✗Anything in medical notes suggesting unsuitable in the opinion of the investigator
  • ✗Eligibility criteria for participation in weight loss arm
  • ✗Inclusion criteria:
  • ✗Written agreement to take part
  • ✗Aged 18 to 40 years (inclusive)
See the full 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 Is This Study? (1 UK site)

Cambridge University Hospitals NHS Foundation Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Data sourced from ClinicalTrials.gov · Last verified: 2026-01