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HypertensionSOLUTION-PilotNCT07364175

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

A study testing Tirzepatide and Anti-Hypertensive medications in people with Hypertension and Obesity & Overweight, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Hypertension, Obesity & Overweight
What is being tested?
Tirzepatide and Anti-Hypertensive medications
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2026to Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
  • Written informed consent
Show all 11Show fewer
  • 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

Who cannot join

  • Anything in medical notes suggesting unsuitable in the opinion of the investigator
  • Eligibility criteria for participation in weight loss arm
  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting
  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire, CB2 0QQ

    James Goodman, MRCP PhD, +44 01223 336806, james.goodman11@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: Standard of Care or Weight Loss Drug Therapy in Obesity-related Hypertension - Pilot Study

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.

Being tested
Tirzepatide, Anti-Hypertensive medications
Keywords
hypertension, obesity, overweight, tirzepatide, GLP-1
Medical subject headings
Hypertension, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for 12 weeks

  • Anti-Hypertensive medicationsDrug

    Anti-hypertensive drug therapy as per local and national guidelines

Study groups in NCT07364175
Study groupRoleWhat they receive
Tirzepatide [weight loss arm]Experimental6 months of treatment with a combined GLP-1/GIP receptor agonist, tirzepatide
Receives: Drug: Tirzepatide
Lifestyle advice and anti-hypertensive medications [standard of Care arm]Active comparatorNot described
Receives: Drug: Anti-Hypertensive medications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ambulatory systolic blood pressure

    Change in daytime ambulatory systolic blood pressure in the weight loss arm

    Measured: Baseline to week 24

Secondary outcomes (55)
  1. Ambulatory diastolic blood pressure

    Change in daytime ambulatory diastolic blood pressure in the weight loss arm

    Measured: Baseline to week 24

  2. Clinic systolic blood pressure

    Changes in clinic systolic blood pressure in the weight loss arm

    Measured: Baseline to week 24

  3. Clinic diastolic blood pressure

    Changes in clinic diastolic blood pressure in the weight loss arm

    Measured: Baseline to week 24

  4. Clinic mean arterial pressure

    Changes in clinic mean arterial pressure in the weight loss arm

    Measured: Baseline to week 24

  5. Unattended systolic blood pressure

    Changes in unattended systolic blood pressure in the weight loss arm

    Measured: Baseline to week 24

  6. Unattended diastolic blood pressure

    Changes in unattended diastolic blood pressure in the weight loss arm

    Measured: Baseline to week 24

  7. Unattended mean arterial pressure

    Changes in unattended mean arterial pressure in the weight loss arm

    Measured: Baseline to week 24

  8. Body weight

    Changes in body weight in the weight loss arm

    Measured: Baseline to week 24

  9. Body fat

    Changes in body fat in the weight loss arm

    Measured: Baseline to week 24

  10. Waist:hip ratio

    Changes in waist:hip ratio in the weight loss arm

    Measured: Baseline to week 24

  11. Cardiac output

    Changes in cardiac output in the weight loss arm

    Measured: Baseline to week 24

  12. Peripheral vascular resistance

    Changes in peripheral vascular resistance in the weight loss arm

    Measured: Baseline to week 24

  13. Pulse wave analysis / pulse wave velocity

    Changes in markers of pulse wave analysis and pulse wave velocity in the weight loss arm

    Measured: Baseline to week 24

  14. Heart rate variability

    Changes in heart rate variability in the weight loss arm

    Measured: Baseline to week 24

  15. Renin

    Changes in plasma renin in the weight loss arm

    Measured: Baseline to week 24

  16. Aldosterone

    Changes in plasma aldosterone in the weight loss arm

    Measured: Baseline to week 24

  17. Plasma metanephrines

    Changes in plasma metanephrines in the weight loss arm

    Measured: Baseline to week 24

  18. Leptin

    Changes in leptin in the weight loss arm

    Measured: Baseline to week 24

  19. Insulin

    Changes in plasma insulin in the weight loss arm

    Measured: Baseline to week 24

  20. Lipid profile

    Changes in the lipid profile in the weight loss arm

    Measured: Baseline to week 24

  21. HbA1C

    Changes in HbA1C in the weight loss arm

    Measured: Baseline to week 24

  22. Estimated glomerular filtration rate

    Changes in eGFR in the weight loss arm

    Measured: Baseline to week 24

  23. N-terminal pro-B-type natriuretic peptide

    Changes in NT-proBNP in the weight loss arm

    Measured: Baseline to week 24

  24. Urine albumin:creatinine ratio

    Change in urine albumin:creatinine ratio in the weight loss arm

    Measured: Baseline to week 24

  25. 24-hour urine sodium

    Change in 24-hour urine sodium in the weight loss arm

    Measured: Baseline to week 24

  26. 24-hour urine aldosterone

    Change in 24-hour urine aldosterone in the weight loss arm

    Measured: Baseline to week 24

  27. Antihypertensive medications

    Change in number of antihypertensive medications

    Measured: Baseline to week 24

  28. Quality of life measures

    Changes in quality of life questionnaire scores in the weight loss arm

    Measured: Baseline to week 24

  29. Ambulatory systolic blood pressure

    Between-group comparison in ambulatory sytolic blood pressure

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  30. Ambulatory diastolic blood pressure

    Between-group comparison in ambulatory diastolic blood pressure

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  31. Clinic systolic blood pressure

    Between-group comparison in clinic systolic blood pressure

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  32. Clinic diastolic blood pressure

    Between-group comparison in clinic diastolic blood pressure

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  33. Clinic mean arterial pressure

    Between-group comparison in clinic mean arterial pressure

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  34. Unattended systolic blood pressure

    Between-group comparison in unattended systolic blood pressure

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  35. Unattended diastolic blood pressure

    Between-group comparison in unattended diastolic blood pressure

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  36. Unattended mean arterial pressure

    Between-group comparison in mean arterial pressure

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  37. Body weight

    Between-group body weight

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  38. Body fat

    Between-group comparison in body fat

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  39. Waist:hip ratio

    Between-group comparison in waist:hip ratio

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  40. Cardiac output

    Between-group comparison in cardiac output

    Measured: At week 24 (weight loss arm) and 6 months (standard of care arm)

  41. Peripheral vascular resistance

    Between-group comparison in peripheral vascular resistance

    Measured: At week 24 (weight loss arm) and 6 months (standard of care arm)

  42. Pulse wave analysis / pulse wave velocity

    Between-group comparison in markers of pulse wave analysis and pulse wave velocity

    Measured: At week 24 (weight loss arm) and 6 months (standard of care arm)

  43. Heart rate variability

    Between-group comparison in heart rate variability

    Measured: At week 24 (weight loss arm) and 6 months (standard of care arm)

  44. Plasma renin

    Between-group comparison in plasma renin

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  45. Plasma aldosterone

    Between-group comparison in plasma aldosterone

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  46. Plasma metanephrines

    Between-group comparison in plasma metanephrines

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  47. Lipid profile

    Between-group comparison in lipid profile

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  48. HbA1C

    Between-group comparison in HbA1C

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  49. Estimated glomerular filtration rate

    Between-group comparison in eGFR

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  50. N-terminal pro-B-type natriuretic peptide

    Between-group comparison in NT-proBNP

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  51. Urine albumin:creatinine ratio

    Between-group comparison in urine albumin:creatinine ratio

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  52. 24-hour urine sodium

    Between-group comparison in 24-hour urine sodium

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  53. 24-hour urine aldosterone

    Between-group comparison in 24-hour urine aldosterone

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  54. Number of antihypertensive medications

    Between-group comparison in the number of anti-hypertensive medications

    Measured: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

  55. Quality of life measures

    Between-group comparison in quality of life questionnaire scores

    Measured: At week 24 (weight loss arm) and 6 months (standard of care arm)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study startJan 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will utilise a modified trial within cohort (TwiC) design for patients under the hypertension/clinical pharmacology clinic. Those who meet the eligibility criteria for randomisation will be randomised to being approached for either: (i) 6 months of treatment with a combined GLP-1/GIP receptor agonist, Tirzepatide \[Group A - Weight loss arm\] (ii) Standard anti-hypertensive treatment and attendance at a 6-month combined research/clinical follow-up visit \[Group B - Standard of Care (SoC) arm\].
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364175
Sponsor's protocol ID
R+D: A097457, REC: 25/WA/0268
Acronym
SOLUTION-Pilot
Status last verified
Jan 2026
First submitted
6 Jan 2026
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Following publication, the data that support the findings of this study will be available from the Chief Investigator/corresponding author upon reasonable request

Questions about this trial

What is this clinical trial studying?

A study testing Tirzepatide and Anti-Hypertensive medications in people with Hypertension and Obesity & Overweight, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ambulatory systolic blood pressure (time frame: Baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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SOLUTION-Pilot Clinical Trial NCT07364175 | AzTrials