A study testing maridebart cafraglutide for weight loss in adults with overweight or obesity, with or without type 2 diabetes

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What is this study about?

This study involves people who are overweight or have obesity, either with or without type 2 diabetes mellitus, which is a condition where the body does not properly control blood sugar levels. The treatment being tested is called AMG 133, which is given as an injection under the skin. Some participants will receive AMG 133 while others will receive placebo. The medication works through a combination that targets certain receptors in the body that help control appetite and blood sugar.

The purpose of this study is to compare different doses of AMG 133 to placebo to see how well they work in helping people lose weight and keep it off over a period of time. The study will look at two groups of people: those who have weight problems without diabetes and those who have weight problems with type 2 diabetes. The study will measure how much weight people lose and whether they can maintain that weight loss.

During the study, participants will receive treatment for up to 104 weeks, which is about two years. The study will track changes in body weight, blood sugar levels measured by a test called hemoglobin A1c or HbA1c, waist size, blood pressure, and various substances in the blood such as cholesterol and triglycerides. Some participants will also have body composition measured using a scanning method called dual-energy X-ray absorptiometry or DXA, which shows how much fat and muscle the body has. The study will also monitor how the medication moves through the body and check for any side effects to determine if the treatment is safe and well-tolerated.

1 Initial screening and enrollment

Your body mass index will be measured to confirm it is at least 27 kg/sq.m.

A blood test will be performed to measure your HbA1c level. This test shows your average blood sugar levels over the past few months.

If you do not have diabetes, your HbA1c must be below 6.5%. If you have type 2 diabetes, your HbA1c must be between 7% and 10%.

If you have type 2 diabetes, you must have been diagnosed for at least 180 days before this screening.

Your medical history will be reviewed to confirm at least one previous unsuccessful weight loss attempt through diet and exercise.

2 Assignment to treatment group

You will be randomly assigned to receive either AMG 133 at one of three dose levels or a placebo.

A placebo is an inactive substance that looks like the actual medication but contains no active ingredient.

Neither you nor the study staff will know which treatment you are receiving. This is called a double-blind study design.

You will be placed in either cohort A if you do not have diabetes, or cohort B if you have type 2 diabetes.

3 Treatment period

You will receive injections of either AMG 133 or placebo under the skin. This is called subcutaneous injection.

The treatment will continue for 52 weeks.

The specific dose and frequency of injections will be determined by the treatment group to which you are assigned.

4 Regular monitoring visits

Throughout the 52-week treatment period, you will attend regular clinic visits.

At these visits, your body weight will be measured and recorded.

Your waist circumference will be measured.

Your blood pressure will be checked, including both the upper number (systolic) and lower number (diastolic).

Blood samples will be taken to measure various health markers.

5 Blood tests during the study

Blood tests will measure your HbA1c levels to track blood sugar control over time.

Your fasting blood sugar and fasting insulin levels will be measured. Fasting means you will not eat for a certain period before the blood draw.

Tests will measure cholesterol levels, including LDL (often called bad cholesterol), HDL (often called good cholesterol), total cholesterol, and triglycerides (a type of fat in the blood).

A marker of inflammation called hs-CRP will be measured.

The amount of study medication in your blood will be measured at certain visits.

6 Body composition assessment

If you are selected for this part of the study, you will undergo a DXA scan.

DXA stands for dual-energy X-ray absorptiometry. This is a special type of X-ray that measures how much fat and lean tissue your body has.

This scan will be performed at the beginning and at week 52 to see how your body composition changes.

7 Assessment at week 52

At week 52, all measurements will be repeated to evaluate the effects of the treatment.

The primary assessment will be the percentage change in your body weight from the beginning of the study.

Additional assessments will determine if you achieved specific weight loss goals, such as losing at least 5%, 10%, 15%, or 20% of your starting body weight.

Changes in blood sugar control, cholesterol levels, blood pressure, and other health markers will be evaluated.

8 Safety monitoring throughout the study

Throughout the entire study period, you will be monitored for any side effects or health concerns.

Any symptoms or health changes should be reported during your clinic visits.

The safety and tolerability of the study medication will be continuously assessed.

Who Can Join the Study?

You must provide your agreement to participate in the study before any study activities begin.
You must be at least 18 years old, or the legal adult age in your country if it is older than 18 years.
Your BMI (body mass index, a measure that uses your height and weight to determine if you are in a healthy weight range) must be 27 or higher at the start of the study.
You must have tried to lose weight through diet and exercise at least once before without success, as determined by the study doctor.
If you are in group A (without diabetes), you must have at least one of the following health problems related to weight: hypertension (high blood pressure), dyslipidemia (abnormal levels of fats in the blood), obstructive sleep apnea (a condition where breathing stops and starts during sleep), or cardiovascular disease (disease of the heart or blood vessels); or your BMI must be 30 or higher.
If you are in group A (without diabetes), your HbA1c (a blood test that shows your average blood sugar level over the past 2 to 3 months) must be less than 6.5% at the start of the study, and you must not have a diagnosis of type 1 or type 2 diabetes.
If you are in group B (with diabetes), your HbA1c must be between 7% and 10% at the start of the study, and you must have been diagnosed with type 2 diabetes (a condition where your body does not use insulin properly) for at least 180 days before the study begins.
If you are in group B (with diabetes), you must be managing your diabetes with diet and exercise alone, or you must be taking stable doses (for at least 90 days before the study) of metformin (a medication that lowers blood sugar), a sulfonylurea (a medication that helps your body release more insulin), or an SGLT2 inhibitor (a medication that helps remove sugar through urine), either alone or in combination.

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria (reasons why you cannot participate) for this clinical trial
This study is focused on people who are overweight (weighing more than is healthy for your height) or have obesity (having excess body fat that may affect health)
The trial includes two groups: people without diabetes mellitus (a condition where blood sugar levels are too high) and people with type 2 diabetes mellitus (a form of diabetes that usually develops in adults)
Both men and women can participate in this study
The study accepts adults and elderly people as participants

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Diabeteszentrum Hamburg West	Hamburg	Germany
Endokrinologicky ustav	Prague	Czechia

Other Sites

Site Name	City	Country
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Athleticomed Sp. z o.o.	Bydgoszcz	Poland
Clinexpert Kft.	Budapest	Hungary
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Budapesti Szent Ferenc Korhaz	Budapest	Hungary
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Of Pecs	Pecs	Hungary
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Centrum Leczenia MIGRE	Wroclaw	Poland
Irydcspbd Fqn Cjjsuvop Axr Eiyithjcxwus Midjiyml	Prague	Czechia
Cvhpmog Bbnhm Kzbrslpzhkk Pxlasqpk Sxz z oahu	Gdansk	Poland
Onmmtgt Bcbwp Kncifofctql Bn Rcofvypq Sbq z otyf	Ilawa	Poland
Chr Hfjidln Kaep	Encs	Hungary
Hgtjuqrs Uiqipalonsxdi dl A Chxsfe	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	13.03.2023
Germany	Not recruiting	13.03.2023
Hungary	Not recruiting	13.03.2023
Poland	Not recruiting	13.03.2023
Spain	Not recruiting	13.03.2023

Trial locations

Investigated drugs:

Maridebart Cafraglutide

AMG 133 is an investigational medication being studied for weight loss in adults who are overweight or obese. This medication is being tested to see if it can help people lose weight and keep the weight off over time. The study is examining how well AMG 133 works compared to a placebo (an inactive treatment) in people who are overweight or obese, including those who have type 2 diabetes and those who do not have diabetes.

Investigated diseases:

Overweight – Overweight is a condition where a person has more body weight than is considered healthy for their height. It occurs when the body accumulates excess fat due to consuming more calories than are burned through daily activities and exercise. The condition develops gradually over time as energy intake consistently exceeds energy expenditure. Overweight can affect various body systems and may impact physical mobility and overall health. The body mass index is commonly used to identify this condition, with values above the normal range indicating excess weight. Without intervention, overweight can progress and lead to additional health complications.

Obesity – Obesity is a chronic condition characterized by excessive accumulation of body fat that affects health and bodily functions. It develops when calorie intake significantly exceeds the amount of energy the body uses over an extended period. The excess fat is stored in various parts of the body, including under the skin and around internal organs. Obesity progresses through different stages, with increasing amounts of fat tissue affecting the body’s normal functioning. The condition can impact multiple organ systems, including the heart, joints, and metabolic processes. Obesity often develops gradually but can become more severe without changes to diet and physical activity levels.

Type 2 Diabetes Mellitus – Type 2 diabetes mellitus is a chronic metabolic disorder in which the body cannot properly use insulin or does not produce enough insulin to maintain normal blood sugar levels. The condition typically develops gradually, often beginning with insulin resistance where cells do not respond effectively to insulin. As the disease progresses, the pancreas may produce less insulin over time. High blood sugar levels persist in the bloodstream because glucose cannot enter cells efficiently. The condition is often associated with excess body weight and physical inactivity. Without proper management, blood sugar levels remain elevated and can affect various organs and tissues throughout the body.

Trial ID:

2023-510470-13-00

Protocol code:

20190218

NCT ID:

NCT05669599

Trial Phase:

Therapeutic exploratory (Phase II)

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A study testing maridebart cafraglutide for weight loss in adults with overweight or obesity, with or without type 2 diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?