Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, Phase 2, dose-finding trial of once weekly petrelintide compared with placebo in participants with obesity or overweight with weight related comorbidities

This research study is looking into a new medicine called petrelintide, which is given once a week. It's for people who are overweight or have obesity and other health issues linked to their weight. The main goal is to find out how much weight people lose over 28 weeks when taking petrelintide compared to a dummy medicine (placebo). They will also check if people lose 5% or 10% of their body weight. The study is in an early stage, focusing on finding the right dose and understanding its effects. It's open to adults aged 18 and over, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Zealand Pharma A/S

Enrolment target

220

Start

16 Dec 2024

Weight management

What is this study about?

This study is investigating a new medication called petrelintide, which is designed to help people manage their weight. It's for adults in the UK who are considered overweight or have obesity and are also dealing with other health conditions linked to their weight. The researchers are giving petrelintide once a week to see if it can help people lose weight effectively.

During the study, some participants will receive the actual petrelintide medicine, while others will get a 'placebo'. A placebo looks exactly like the real medicine but contains no active drug. This helps the researchers understand if any changes seen are truly due to the new medicine or if they might happen anyway. The main thing they will measure is how much body weight people lose, in percentage terms, over 28 weeks.

This is an important step in developing new treatments for weight management. By carefully comparing petrelintide with a placebo, the researchers hope to learn if it's a promising option that could eventually help many people improve their health.

Key takeaways

This study is testing a new weekly weight loss drug called petrelintide.
It's for adults who are overweight or have obesity and related health issues.
Participants will receive either the new medicine or a dummy treatment.
The study measures weight loss over a 28-week period.
It aims to find the right dose and understand the medicine's effects.
Participation involves regular clinic visits for checks and medication.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

It's specifically for people who are overweight or have obesity and also have other health problems that are connected to their weight. The research team will check your health carefully to make sure the study is a good fit for you and that it's safe for you to take part.

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 18 years old or older?
Are you considered overweight or do you have obesity?
Do you have any health problems that are linked to your weight?
Are you willing to take a weekly study medication?
Can you attend regular clinic appointments for 28 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a total of 28 weeks, which is about 7 months. During this time, you will have regular visits to the study clinic. At these visits, the research team will check your health, take measurements like your weight, and collect samples (like blood tests). You will be given either the study medication (petrelintide) or a placebo, which you will take once a week. There will also be follow-up activities to monitor your progress and well-being after you finish taking the medication.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new medication that could help with weight loss, and having regular medical check-ups. However, there are also potential risks; the new medication might have side effects that we don't fully know about yet. There's also no guarantee that the treatment will work for you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland
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Unverified
Romania

Common questions

What is petrelintide?

Petrelintide is a new medicine being tested to see if it can help people manage their weight.

What does 'placebo' mean?

A placebo is a fake medicine that looks like the real thing but has no active ingredients. It helps researchers compare the effects of the new drug.

How long will the study last?

The main part of the study where you take the medication will last for 28 weeks, which is about 7 months.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know if you're getting petrelintide or the placebo. This is to make the study fair and accurate.

What happens after the study ends?

After you finish the 28-week treatment, there will be follow-up visits to check on your health and see how you are doing.