Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C5541010 - A PHASE 2A, RANDOMIZED, DOUBLE BLIND, SPONSOR OPEN, PLACEBO CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY OF PF 07976016 TO ASSESS SAFETY AND EFFICACY IN ADULT PARTICIPANTS WITH OBESITY

This study is looking into a new medication called PF-07976016 for adults who are overweight or have obesity. It's a phase 2a study, which means it's an early stage of testing to see how safe the new medicine is and how well it works. Participants will be divided into groups and will either receive the new medicine, a well-known weight-loss injection called Saxenda, or a "placebo" (a dummy medicine with no active ingredients). The main goal is to see how much weight people lose after 16 weeks and to monitor for any side effects. Researchers will also check overall health, including mental well-being, throughout the study to ensure safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

Start

13 Mar 2025

Obesity Overweight

What is this study about?

This study is specifically designed to understand more about a new medicine, PF-07976016, which could potentially help people manage overweight or obesity. It's an important early step in developing new treatments. The researchers want to find out if this new medicine is safe for people to take and if it can help them lose weight. They are also trying to figure out the best amount, or 'dose', of the new medicine to use.

To do this fairly, some participants will receive the new medicine, some will receive Saxenda (which is an approved medicine for weight loss that doctors already prescribe), and others will receive a 'placebo'. A placebo looks exactly like the real medicine but contains no active ingredients. This helps researchers compare the effects accurately. Participants won't know which treatment they are getting, nor will their doctors, until the study is over. This is called a 'double-blind' study and helps ensure the results are unbiased.

The main thing researchers will be looking at is how much body weight participants lose over 16 weeks. They will also carefully check for any side effects and monitor general health, including things like blood tests, heart health, and mood, to make sure the medicine is not causing any unexpected problems. This careful monitoring is crucial in the early stages of testing a new medicine.

Key takeaways

This study is testing a new medicine for obesity.
It aims to see if the medicine is safe and helps with weight loss.
Participants will receive the new medicine, an existing medicine (Saxenda), or a placebo.
The study lasts 16 weeks, with close health monitoring.
You won't know which treatment you are getting until the study ends.

Who may be eligible?

This study is looking for adults who are 18 years old or older. Both men and women are welcome to take part.

To be considered for this study, you would need to have been diagnosed as being overweight or having obesity. The researchers will have specific height-to-weight and health criteria to make sure the study includes people who are a good fit for this particular research.

It's important to remember that this is a general guide. Many other factors, often related to your medical history and current health, will determine if you can actually join the study. If you're interested, the study team will go through a detailed check with 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 18 years old or older?
Have you been diagnosed as overweight or having obesity?
Are you able to attend regular clinic visits?
Do you understand that you might receive a placebo?
Are you comfortable with injections if that is the method of treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine, Saxenda, or a placebo, given as an injection using a pre-filled pen. The study will last for a specific period of time, starting with 16 weeks where your weight and health will be closely monitored.

During your time in the study, you would have regular visits to the clinic. At these visits, doctors and nurses will assess your weight, take blood samples, check your heart, and ask questions about your general health and how you are feeling, including your mood. These assessments are important to track how the medicine is working and to ensure your safety. All medications, visits, and tests related to the study will be provided at no cost, but you would be responsible for travel to and from the clinic.

Potential risks and benefits

Taking part in a clinical trial could offer the benefit of receiving a new, potentially effective treatment for overweight or obesity before it's widely available. You'll also receive close medical attention and monitoring throughout the study. However, there are always potential risks, including side effects from the study medication or the possibility that the treatment may not work for you, or that you might receive the placebo. The researchers will carefully monitor you for any side effects, including changes in your physical and mental health. 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
Hungary
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Unverified
Poland

Common questions

What is a 'placebo'?

A placebo is a dummy medicine containing no active ingredients. It looks just like the real medicine, and is used to compare the effects fairly.

What is Saxenda?

Saxenda is an approved medicine that doctors can prescribe for weight loss. It is an injection you give to yourself, similar to how people with diabetes might inject insulin.

Will I know which treatment I am getting?

No, neither you nor the study doctors will know if you are receiving the new medicine, Saxenda, or the placebo until the study is over. This helps ensure the results are fair.

Who is paying for this study?

This study is sponsored by a pharmaceutical company, which means they are providing the funding and the new medicine being tested.

What does a 'phase 2a' study mean?

Phase 2a means this is an early stage study to check the safety of the new medicine and see how well it works, as well as to find the best dose to use in future studies.