ClinicalTrials.gg
RecruitingNCT07680205Updated Jul 2, 2026

An Experimental Study of Belzutifan Impact on Catecholamine Metabolism

A Phase 2 interventional study of Belzutifan in Pheochromocytoma and Paraganglioma (PPGL), Pheochromocytoma Malignant and Pheochromocytoma, Metastatic, sponsored by Cambridge University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Pheochromocytoma with a site in United Kingdom — 5 open to participants now, 6 under way, none of them phase 3. Pheochromocytoma · United Kingdom.

Started
2026
the only one that year
Phase 2
3 of 10
2 open now
Registered
10th of 10
by date
Lead sponsor
1 of 10
Cambridge University Hospitals NHS Foundation Trust

Among the 10 studies in Pheochromocytoma with a site in United Kingdom, this one is the only one that started in 2026, is one of 3 in phase 2, and was the 10th registered.

Pheochromocytoma

158 studies on the registry are indexed under Pheochromocytoma; 57 are open to participants now.

Browse Pheochromocytoma studies →

Open to participants now

5 of the 10 studies in Pheochromocytoma with a site in United Kingdom are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 43 Pheochromocytoma studies recruiting now, 22 (51%) set no upper age limit and 6 (14%) stop at 75 or younger; 19 take children under 18; 4 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Pheochromocytoma with a site in United Kingdom, or all of them as a file.
02

Study summary

To investigate the impact of a medication called Belzutifan on the production and subsequent metabolism of adrenaline and noradrenaline collectively termed 'catecholamines'. The study aims to identify changes in the production and metabolism of catecholamines by measuring the substance which starts the chain of catecholamine metabolism called tyrosine in patients before, during and after 5 days of taking Belzutifan 120mg daily.

Read the detailed description

This is a single centre, single arm, pilot interventional study aimed at identifying alterations in catecholamine synthesis and metabolism in 12 patients taking Belzutifan 120mg daily for five days. As this is a pilot and experimental study of a rare disease, sample size was not calculated. A study recruitment target of 12 patients was established based on the annual incidence of patients with catecholamine secreting PPGL attending our national referral centre.

There is an estimated annual incidence of 100-150 patients across all of England and an annual incidence of 15-20 patients attending Cambridge University Hospital per year.

The study protocol is 14 days. All patients will be recruited by the PI after informed consent and review of the study inclusion and exclusion criteria.

Germline genetic results performed as part of routine clinical care will be recorded for all patients. For those patients with negative germline genetic test results, tumour sequencing of available tissue or tumour tissue later removed (after the end of the study protocol) during surgery will be performed to investigate for somatic variants (genetic changes unique to the tumour cells) in specific genes which may influence how Belzutifan impacts catecholamine synthesis and metabolism.

The study protocol is 14 days including five days of intervention with Belzutifan 120mg daily for all patients. Baseline plasma tyrosine and plasma metanephrines will be performed on all patients (day 0) and at several time points after starting Belzutifan 120mg daily to examine for alterations in catecholamine metabolism. Recruited patients will attend daily for seven days and again on day 10 and day 14 and will be reviewed by the PI.

Plasma tyrosine and metanephrines will be performed using specific published research methods (liquid chromatography mass spectroscopy) and a percentage reduction in catecholamine metabolites and a percentage increase in tyrosine will be calculated for every patient at the end of the 14-day protocol.

Safety measures will include monitoring of full blood count, liver function tests and by measuring blood pressure and heart rate at baseline and at day 1-7, day 10 and day 14 in all patients recruited to the study.

Any changes in blood pressure during the study protocol will be reviewed by the PI and all changes to existing medications will be performed by the PI and recorded.

All recruited patients will be interviewed daily from day 0 to day 7 and again on day 10 and day 14 and all symptoms reported will be recorded by the PI.

03

Conditions studied

  • Pheochromocytoma and Paraganglioma (PPGL)
  • Pheochromocytoma Malignant
  • Pheochromocytoma, Metastatic
  • Pheochromocytoma/Paraganglioma
  • Pheochromocytoma

Keywords

  • Belzutifan
  • catecholamine synthesis
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients > 18 years
  • Patients must have a biochemically confirmed diagnosis of a phaeochromocytoma or paraganglioma using plasma metanephrines or 24- hour urinary metanephrines and plasma or urinary metanephrines should be at least 1.5 times the reference range.
  • Female patients of must have a negative serum pregnancy test result within 3 days before first administration of study drug
  • Able to provide

Exclusion criteria

Exclusion Criteria:

  • Has hypoxia, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
  • Has cardiac disease, including unstable angina, acute myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass graft surgery (CABG) ≤6 months from Day 1 of study drug administration, or Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.
  • Has a co-existing (in addition to PPGL)
  • Has a \< 100g/dL
  • Is on medications which may interfere with belzutifan pharmacokinetics and that cannot be stopped for the duration of the study and for 7 days after the study period (everolimus, omeprazole, esomeprazole, Fluconazole, fluoxetine, Voriconazole, Sirolimus)
  • Has a known diagnosis of , or
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Intervention

    For 14 day study protocol, including five days of intervention with Belzutifan

    Drug: Belzutifan

Interventions

06

What researchers measure

Primary outcomes

  1. Tyrosine measurements

    The quantitative change in the amino acid tyrosine from baseline to the end of the study intervention (day 5) and to the end of the study (day 14).

    Time frame: Baseline, day 5 and day 14

Secondary outcomes

  1. Plasma metanephrine measurements

    Quantitative changes in serial plasma metanephrines measured at baseline, at the end of the study intervention (day 5) and at the end of the study (day 14).

    Time frame: Baseline, day 5 and day 15

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Lenders JW, Duh QY, Eisenhofer G, Gimenez-Roqueplo AP, Grebe SK, Murad MH, Naruse M, Pacak K, Young WF Jr; Endocrine Society. Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Jun;99(6):1915-42. doi: 10.1210/jc.2014-1498. PubMed 24893135 ↗
  • Tufton N, Gunganah K, Hussain S, Druce M, Carpenter R, Ashby M, Drake WM, Akker SA. Alpha blockade-not to be underdone. Clin Endocrinol (Oxf). 2017 Feb;86(2):306-308. doi: 10.1111/cen.13262. Epub 2016 Nov 21. No abstract available. PubMed 27761935 ↗
  • Buffet A, Burnichon N, Favier J, Gimenez-Roqueplo AP. An overview of 20 years of genetic studies in pheochromocytoma and paraganglioma. Best Pract Res Clin Endocrinol Metab. 2020 Mar;34(2):101416. doi: 10.1016/j.beem.2020.101416. Epub 2020 Mar 10. PubMed 32295730 ↗
  • Winzeler B, Tufton N, S Lim E, Challis BG, Park SM, Izatt L, Carroll PV, Velusamy A, Hulse T, Whitelaw BC, Martin E, Rodger F, Maranian M, Clark GR, A Akker S, Maher ER, Casey RT. Investigating the role of somatic sequencing platforms for phaeochromocytoma and paraganglioma in a large UK cohort. Clin Endocrinol (Oxf). 2022 Oct;97(4):448-459. doi: 10.1111/cen.14639. Epub 2021 Dec 6. PubMed 34870338 ↗
  • Winzeler B, Challis BG, Casey RT. Precision Medicine in Phaeochromocytoma and Paraganglioma. J Pers Med. 2021 Nov 22;11(11):1239. doi: 10.3390/jpm11111239. PubMed 34834591 ↗
  • Nazari MA, Hasan R, Haigney M, Maghsoudi A, Lenders JWM, Carey RM, Pacak K. Catecholamine-induced hypertensive crises: current insights and management. Lancet Diabetes Endocrinol. 2023 Dec;11(12):942-954. doi: 10.1016/S2213-8587(23)00256-5. Epub 2023 Nov 6. PubMed 37944546 ↗
  • Gruber LM, Jasim S, Ducharme-Smith A, Weingarten T, Young WF, Bancos I. The Role for Metyrosine in the Treatment of Patients With Pheochromocytoma and Paraganglioma. J Clin Endocrinol Metab. 2021 May 13;106(6):e2393-e2401. doi: 10.1210/clinem/dgab130. PubMed 33693908 ↗
  • Casey RT, Challis BG, Pitfield D, Mahroof RM, Jamieson N, Bhagra CJ, Vuylsteke A, Pettit SJ, Chatterjee KC. Management of an acute catecholamine-induced cardiomyopathy and circulatory collapse: a multidisciplinary approach. Endocrinol Diabetes Metab Case Rep. 2017 Nov 9;2017:17-0122. doi: 10.1530/EDM-17-0122. eCollection 2017. PubMed 29147570 ↗
  • Alkaissi H, Nazari MA, Hadrava Vanova K, Uher O, Gordon CM, Talvacchio S, Diachenko N, Mukvich O, Wang H, Glod J, Zhuang Z, Pacak K. Rapid Cardiovascular Response to Belzutifan in HIF2A-Mediated Paraganglioma. N Engl J Med. 2024 Oct 24;391(16):1552-1555. doi: 10.1056/NEJMc2409427. No abstract available. PubMed 39442048 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.

Of 28 phase 2 interventional studies under Pheochromocytoma, half reached primary completion within 92 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 157. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2026
First posted
Jul 2, 2026
StartActual
Apr 27, 2026
Primary completionEst.
Apr 2027
CompletionEst.
Dec 2027
Last update
Jul 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07680205
Responsible party
Ruth Casey (Principal Investigator, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Jul 2, 2026
Start date
Apr 27, 2026
Primary completion
Apr 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 2, 2026

Study contacts

August Palma Senior Research Nurse - Endocrinology
Contact
august.palma@nhs.net
01223 217 848
Ruth T Casey, MD PhD
principal investigator · Cambridge University Hospital and University of Cambridge

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Belzutifan

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