Standard of Care or Weight Loss Drug Therapy in Obesity-related Hypertension - Pilot Study
New trial tests weight loss drug for high blood pressure in young adults
Plain English Summary
A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults is a Not Applicable clinical trial sponsored by Cambridge University Hospitals NHS Foundation Trust studying Hypertension, Obesity & Overweight. This study compares a weight loss drug (tirzepatide) to standard treatments for high blood pressure in young adults with obesity. It is for individuals aged 18-40 who have high blood pressure linked to their weight. Participants will either receive the weight loss drug or standard blood pressure medications and lifestyle advice. Alternatives include lifestyle changes (diet, exercise) and existing blood pressure medications. The trial aims to enroll 60 participants.
Official 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. 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-
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 40 years old, have a BMI of 27 or higher, and have high blood pressure that isn't controlled by more than one medication. You cannot join if you have certain other medical conditions like diabetes, kidney problems, heart issues, or a history of pancreatitis. The study is looking for people with primary hypertension (high blood pressure with no known cause) and not secondary hypertension (high blood pressure caused by another medical condition). This trial is studying Hypertension, Obesity & Overweight, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see how much the weight loss drug reduces blood pressure over 24 weeks, aiming for a significant drop in systolic blood pressure. The specific primary outcome measures are: Ambulatory systolic blood pressure (Baseline to week 24). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a significant gap in treating high blood pressure in young adults, where obesity is a major contributing factor and current lifestyle interventions are often not enough. This research targets Hypertension, Obesity & Overweight, where improved treatment options are needed.
Investor Insight
This trial explores a novel approach to managing obesity-related hypertension, a large and growing market, with potential for significant impact if successful, given the limitations of current treatme
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, especially about the weight loss drug and its potential side effects. Participation involves regular clinic visits for blood pressure monitoring, medication, and potentially lifestyle coaching. You will be randomly assigned to either the weight loss drug group or the standard care group. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 60 participants
Interventions
- DRUG: Tirzepatide — 2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for 12 weeks
- DRUG: Anti-Hypertensive medications — Anti-hypertensive drug therapy as per local and national guidelines
Primary Outcomes
- Ambulatory systolic blood pressure (Baseline to week 24)
Secondary Outcomes
- Ambulatory diastolic blood pressure (Baseline to week 24)
- Clinic systolic blood pressure (Baseline to week 24)
- Clinic diastolic blood pressure (Baseline to week 24)
- Clinic mean arterial pressure (Baseline to week 24)
- Unattended systolic blood pressure (Baseline to week 24)
Trial Locations
- Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom
Frequently Asked Questions
What is clinical trial NCT07364175?
NCT07364175 is a Not Applicable INTERVENTIONAL study titled "A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults." It is currently recruiting and is sponsored by Cambridge University Hospitals NHS Foundation Trust. The trial targets enrollment of 60 participants.
What conditions does NCT07364175 study?
This trial investigates treatments for Hypertension, Obesity & Overweight. The primary condition under study is Hypertension.
What treatments are being tested in NCT07364175?
The interventions being studied include: Tirzepatide (DRUG), Anti-Hypertensive medications (DRUG). 2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for 12 weeks
What does Not Applicable mean for NCT07364175?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07364175?
This trial is currently "Recruiting." It started on 2026-01. The estimated completion date is 2029-01.
Who is sponsoring NCT07364175?
NCT07364175 is sponsored by Cambridge University Hospitals NHS Foundation Trust. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07364175?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT07364175 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07364175?
The primary outcome measures are: Ambulatory systolic blood pressure (Baseline to week 24). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07364175 being conducted?
This trial is being conducted at 1 site, including Cambridge, Cambridgeshire (United Kingdom).
Where can I find official information about NCT07364175?
The official record for NCT07364175 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07364175. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07364175 testing in simple terms?
This study compares a weight loss drug (tirzepatide) to standard treatments for high blood pressure in young adults with obesity. It is for individuals aged 18-40 who have high blood pressure linked to their weight.
Why is this trial significant?
This trial addresses a significant gap in treating high blood pressure in young adults, where obesity is a major contributing factor and current lifestyle interventions are often not enough.
What are the potential risks of participating in NCT07364175?
Common side effects of tirzepatide can include nausea, vomiting, diarrhea, and constipation. There's a risk of more serious side effects like pancreatitis, gallbladder problems, or allergic reactions. Blood pressure medications can also have side effects, such as dizziness or fatigue. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07364175?
Ask your doctor if this trial is right for you, especially about the weight loss drug and its potential side effects. Participation involves regular clinic visits for blood pressure monitoring, medication, and potentially lifestyle coaching. You will be randomly assigned to either the weight loss drug group or the standard care group. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07364175 signal from an investment perspective?
This trial explores a novel approach to managing obesity-related hypertension, a large and growing market, with potential for significant impact if successful, given the limitations of current treatme This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will either receive the weight loss drug or standard blood pressure medications and lifestyle advice. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.