RecruitingNot ApplicableInterventional

Physiological study of kisspeptin in post-menopausal health

This study is investigating a natural hormone called kisspeptin in women who have gone through menopause. Many women experience changes after menopause, like issues with their liver, bones, and memory. Kisspeptin is naturally found in the body and early studies suggest it might help with these concerns. We aim to find out if taking kisspeptin over a longer period can improve liver health, make bones stronger, and help with memory or 'brain fog' in post-menopausal women. By taking part, you could help us learn more and potentially develop new treatments for conditions related to menopause.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

Imperial College London

Enrolment target

Start

01 Jul 2025

Estimated completion

31 May 2029

Post-menopausal women who are at a higher risk of conditions affecting the liver, bone and brain.

What is this study about?

Menopause is a natural stage in a woman's life, usually happening between the ages of 45 and 55, when periods stop and the body produces less female hormones. This can lead to a number of changes, including anxiety, mood swings, trouble sleeping, and sometimes memory issues often called 'brain fog'. Beyond these immediate symptoms, menopause can also increase the risk of developing longer-term health problems like liver disease (where fat builds up in the liver), weaker bones (osteoporosis), and ongoing memory problems.

One common condition is Metabolic dysfunction-associated steatotic liver disease (MASLD), which affects about one in three adults in the UK. It's particularly a concern for post-menopausal women. We also know that bone thinning is more likely after menopause, increasing the risk of broken bones.

This study focuses on a hormone called kisspeptin, which our bodies naturally produce. It's known to play a role in fertility, and animal studies suggest it might help reduce fat and inflammation in the liver. In short human studies, kisspeptin has also shown positive effects on mood, how people behave, and bone health. Our goal is to understand if giving kisspeptin for a longer time can genuinely help improve the liver, bones, and memory in women who have gone through menopause.

Key takeaways

Exploring if natural hormone kisspeptin helps post-menopausal women.
Focuses on improving liver health, bone strength, and memory.
Involves daily injections (kisspeptin or placebo) for 12 weeks.
Requires regular hospital visits for tests and scans.
Participation helps future understanding and potential new treatments.
Study runs till July 2029, funded by NIHR.

Who may be eligible?

We are looking for women who have gone through menopause. This means you haven't had a period for at least 12 months and have specific hormone levels. You should also have a liver condition called MASLD, where fat builds up in the liver.

To join, you should either not be taking any regular medications, or your current medications should have been stable (no significant changes) for the past three months. Your weight should also have been stable for at least three months, or for a year if you've had weight-loss surgery recently.

There are also some reasons you might not be able to take part. For example, if you are pregnant, have certain other serious health conditions, or have had a recent bone fracture (not involving hands or feet). We'll discuss all these details with you during the screening process to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman who has not had a period for at least 12 months?
Do you have a liver condition called MASLD?
Are your current medications stable (or are you not taking any)?
Has your weight been stable in the last 3-12 months?
Are you between 40 and 80 years old?

Answer every question to see your result.

What does participation involve?

If you are interested, you'll first answer a short questionnaire. If suitable, you'll be invited for a screening visit at Charing Cross Hospital. This visit includes a physical check-up, blood tests, a heart check (ECG), and a chance to ask any questions. We'll let you know within a week if you can join.

If you join, you'll be randomly chosen to receive daily injections at home for 12 weeks. You'll either receive kisspeptin or a 'placebo' (salty water that looks the same but has no medicine). Before starting injections, you'll have a longer visit (up to 5 hours) to complete questionnaires and memory tests. You'll also have scans, including an MRI and a FibroScan for your liver, and a special X-ray (DEXA scan) to check your bone thickness. These scans will take place at an Imperial College Healthcare NHS Trust hospital in London.

During the 12 weeks of injections, you'll visit the Clinical Research Unit at Charing Cross Hospital every other week. These visits will be up to 3 hours long. Some visits (weeks 1, 6, 12) will be longer, up to 5 hours. There will also be one follow-up visit 12 weeks after you stop the injections. The study is expected to run from May 2024 to July 2029.

Potential risks and benefits

There are potential benefits to taking part. Kisspeptin *might* help with your liver, bones, or memory while you're receiving the injections, but this is not yet known. The blood tests and scans you receive could also provide useful information about your general health, which we would share with your GP with your permission. Your participation is valuable as it helps us learn more about kisspeptin and menopause, which could lead to new treatments in the future. Risks are generally mild: you might experience slight pain or bruising around the injection site. The DEXA scans involve a very small amount of radiation, similar to a chest X-ray, which adds a tiny increase to your lifetime cancer risk. While past studies with kisspeptin haven't shown serious side effects, unforeseen reactions are always a possibility, but you will be closely monitored by a doctor throughout the study. You are free to withdraw from the study at any time.

Locations (1)

Imperial College London
Approximate
London, United Kingdom

Common questions

What is menopause?

Menopause is a natural time in a woman's life, usually between 45 and 55, when her periods stop and her body produces less female hormones.

What is kisspeptin?

Kisspeptin is a hormone made naturally by your body, found in the brain and other areas, and it plays a role in fertility and potentially other body functions.

What is a placebo?

A placebo is a substance that looks exactly like the actual treatment (in this case, an injection) but contains no medicine, like salty water. It helps us fairly compare the effects of the real treatment.

How long will I be in the study?

You will receive injections for 12 weeks, with regular visits during this time, and one follow-up visit 12 weeks after the injections stop.

Where is the study happening?

The study visits and scans will take place in hospitals affiliated with Imperial College Healthcare NHS Trust in London, mainly Charing Cross Hospital.

How to find out more

Kisspeptin Research Team

imperial.kisspeptin@nhs.net 07845883620 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.