Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

I8F-MC-GPHJ: A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide 2.4 mg in Adults Who Have Obesity or Overweight with Weight-Related Comorbidities

This medical study is looking at two different medicines, Tirzepatide and Semaglutide, to understand how well they work and how safe they are for adults living with obesity or who are overweight and have other health problems linked to their weight. The main goal is to compare how much weight people lose with each medicine. Researchers will also be checking other important health changes, such as how much waist size changes and improvements in Body Mass Index (BMI). This type of study, called a Phase 3b trial, is an important step to confirm the effects of new treatments in a larger group of people before they might become more widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Eli Lilly & Co.

Enrolment target

143

Start

26 Jan 2023

Obesity Overweight

What is this study about?

This study, called I8F-MC-GPHJ, is designed to compare two different medicines, Tirzepatide and Semaglutide. Both medicines are being looked at to see how well they help adults with obesity or who are overweight, and who also have other health conditions often linked to their weight, to lose weight. Think of it like comparing two different tools to see which one does a better job and is easier to use for a particular task.

The main thing the researchers want to find out is how much weight people lose when taking one medicine compared to the other. They'll be carefully measuring weight changes from the very beginning of the study. Beyond just overall weight loss, they are also interested in how many people achieve significant weight loss – for example, losing 10%, 15%, 20%, or even 25% of their starting body weight. They will also measure other important health markers like changes in waist size and Body Mass Index (BMI), which are key indicators of health.

This is a 'Phase 3b' trial, which means both medicines have already gone through earlier testing. This phase helps doctors and researchers get a really clear picture of how effective and safe these treatments are when used by a wider range of people in a carefully controlled way. The results of this study will help us understand more about the best ways to help people manage their weight and related health conditions.

Key takeaways

This study compares two medicines for weight loss: Tirzepatide and Semaglutide.
It's for adults with obesity or who are overweight with related health conditions.
Researchers will measure weight loss and other health changes like waist size.
You won't know which medicine you are given in this type of study.
Participation involves regular clinic visits and close medical supervision.
You can stop participating at any time without affecting your usual care.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate. The study is specifically for people who are living with obesity, or who are overweight and have other health issues that are connected to their weight.

It's important to remember that these are just the basic conditions. There will be other specific health requirements and checks that a study doctor will need to go through with you to make sure the study is a safe and suitable option for you. Not everyone who fits the general description will be able to join.

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?
Do you consider yourself to be living with obesity or are you overweight?
Do you have other health conditions that are linked to your weight?
Are you able to attend regular clinic appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given one of the two study medicines, Tirzepatide or Semaglutide, and you won't know which one you are taking. You will have regular visits to the study clinic where the research team will monitor your health, measure your weight, waist circumference, and take blood samples. These visits are important for tracking your progress and making sure you are safe. The medicines are given as an injection, and the study team will show you exactly how to do this safely.

You'll be carefully followed up throughout the study period. The exact number of visits and the total length of time you'll be involved will be explained in detail by the study team. Usually, studies like this involve multiple appointments over several months to accurately measure the effects of the medicines.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving one of the study medicines with close medical supervision that you might not otherwise have access to. The information gained will also help future patients. However, there are also potential risks; side effects can occur with any medication, and the study medicines might not work for everyone. You will be told about all known potential side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
Belgium
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Unverified
Poland

Common questions

What is obesity or being overweight in this study?

In this study, 'obesity' or 'overweight' refers to specific ranges of Body Mass Index (BMI) or body weight that relate to health, combined with having other health problems associated with weight.

What do the medicines, Tirzepatide and Semaglutide, do?

Both Tirzepatide and Semaglutide are types of medicine that can help with weight management and affect how your body handles sugar. This study is comparing how effective they are for weight loss.

Will I know which medicine I am taking?

No, this is a 'randomised controlled study', which means participants are put into groups by chance and neither you nor the study team will know which medicine you are receiving. This helps make the study results fair.

How long will the study last?

The exact total duration of your participation will be fully explained by the study team; studies of this type usually involve follow-up over several months.

What is a 'Phase 3b' study?

A Phase 3b study means the medicines have already undergone initial testing, and this phase aims to confirm their effects and safety in a larger group of people over a longer period, often looking at specific benefits.