Study on the Effectiveness and Safety of Orforglipron for Weight Management in Adolescents with Obesity or Overweight

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for adolescents who have been diagnosed with obesity or are overweight with related health issues. The treatment being tested is called Orforglipron (also known by its code name LY3502970), which is taken as a capsule by mouth. The purpose of the study is to see if Orforglipron can help reduce body weight more effectively than a placebo.

Participants in the study will be randomly assigned to receive either Orforglipron or a placebo. The study will last for a period of time, during which participants will take the medication daily. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their body weight. The main goal is to observe the percent change in Body Mass Index (BMI) from the start of the study to the end.

This trial aims to provide valuable information on the safety and effectiveness of Orforglipron in managing weight in young people with obesity or overweight conditions. The study is designed to ensure the well-being of participants while gathering important data that could lead to new treatment options for weight management in adolescents.

1 joining the study

Upon joining the study, participants are confirmed to have obesity or overweight with at least one related health issue, such as high blood pressure or type 2 diabetes.

Participants have previously been unable to lose weight through diet and exercise alone.

2 initial assessment

An initial assessment is conducted to establish a baseline for the participant’s Body Mass Index (BMI).

This baseline will be used to measure changes over the course of the study.

3 medication administration

Participants are randomly assigned to receive either the study medication, orforglipron, or a placebo.

The medication is taken orally in the form of a capsule once daily.

4 ongoing monitoring

Participants are monitored regularly to assess the efficacy and safety of the treatment.

Regular check-ins include measuring changes in BMI and monitoring for any side effects.

5 completion of study

The study is designed to last until December 15, 2026.

The primary goal is to observe the percent change in BMI from the start of the study to week 72.

Who Can Join the Study?

Must have been diagnosed with obesity or overweight. This means having a higher body weight than what is considered healthy for a certain height.
Must have at least one weight-related comorbidity. This is a medical condition that occurs along with obesity or overweight, such as:
- Abnormal lipids: This refers to having unhealthy levels of fats in the blood.
- High blood pressure: This is when the force of the blood against the artery walls is too high.
- Fatty liver disease: This is a condition where fat builds up in the liver.
- Sleep apnea: This is a sleep disorder where breathing repeatedly stops and starts.
- Prediabetes: This is a condition where blood sugar levels are higher than normal but not high enough to be considered diabetes.
- Type 2 diabetes: This is a condition that affects the way the body processes blood sugar.
Must have tried to lose weight with a healthy diet and physical activity but have not been successful.
Both men and women can participate.
Participants must be within the specified age range for the study.

Who Cannot Join the Study?

Individuals who are not within the specified age range for the study.
Individuals who do not have a BMI (Body Mass Index) that qualifies them as obese or overweight.
Individuals who are part of a vulnerable population that the study is not designed to include.
Individuals who have medical conditions or are taking medications that could interfere with the study results.
Individuals who are unable to comply with the study procedures or follow-up requirements.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Instytut Diabetologii Sp. z o.o.	Warsaw	Poland
Universita’ Degli Studi Di Verona	Verona	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.03.2025
Poland	Recruiting	01.03.2025

Trial locations

Orforglipron: This medication is being tested to see if it can help reduce body mass index (BMI) in adolescents who are either obese or overweight with related health issues. It is taken orally once a day and is being compared to a placebo to determine its effectiveness and safety in managing weight.

Investigated diseases:

Obesity – A condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake exceeds the amount of calories burned, leading to weight gain. Over time, this can result in increased body mass index (BMI) and may affect physical mobility and energy levels. Obesity is often associated with lifestyle factors such as diet and physical activity, but genetics can also play a role. It can lead to various health issues, including joint problems and fatigue.

Overweight – A condition where an individual has more body weight than is considered healthy for their height. It occurs when there is an imbalance between calories consumed and calories expended. This condition can gradually develop due to poor dietary habits and lack of physical activity. Being overweight can lead to increased BMI and may cause discomfort or reduced physical endurance. It is often a precursor to obesity if not managed appropriately.

Trial ID:

2024-514081-40-00

Protocol code:

JAM-MC-PWMP, -PW01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Orforglipron for Weight Management in Adolescents with Obesity or Overweight

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?