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Study on Maridebart Cafraglutide for Adults with Type 2 Diabetes and Obesity or Overweight

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called maridebart cafraglutide on adults with Type 2 Diabetes Mellitus who are either overweight or have obesity. The treatment is administered as a solution for injection and is being compared to a placebo. The main goal of the study is to determine if maridebart cafraglutide can lead to a greater reduction in body weight compared to the placebo.

Participants in the study will receive either maridebart cafraglutide or a placebo over a period of 72 weeks. Throughout the study, changes in body weight, waist circumference, and other health markers such as blood pressure and blood sugar levels will be monitored. The study will also assess the impact of weight changes on the quality of life of the participants.

The study aims to provide valuable information on the effectiveness and safety of maridebart cafraglutide for managing weight in individuals with Type 2 Diabetes Mellitus. This research could potentially lead to new treatment options for those struggling with weight management in the context of diabetes.

1 initial visit

Upon joining the study, the first step involves an initial visit. During this visit, a healthcare professional will explain the study procedures and answer any questions. Consent will be confirmed, ensuring understanding of the study’s purpose and requirements.

Basic health measurements will be taken, including weight, height, and waist circumference. Blood samples may be collected to assess health markers such as blood sugar levels and hemoglobin A1c, which is a measure of blood sugar control over time.

2 randomization

Participants will be randomly assigned to receive either the study medication, maridebart cafraglutide, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the study drug.

This process is double-blind, meaning neither the participant nor the study team will know which treatment is being received, to ensure unbiased results.

3 medication administration

The study medication or placebo will be administered as a solution for injection under the skin, known as subcutaneous use. The frequency and dosage will be determined by the study protocol and communicated during the initial visit.

Participants will be instructed on how to self-administer the injections or will receive them during study visits, depending on the study’s design.

4 regular follow-up visits

Regular follow-up visits will be scheduled throughout the study duration, which is approximately 72 weeks. These visits are essential for monitoring health status, medication effects, and any side effects.

During these visits, health measurements will be repeated, and participants may be asked to complete questionnaires about their health and quality of life.

5 self-monitoring

Participants will be required to perform self-monitoring of blood glucose as per the study protocol. This involves checking blood sugar levels at home using a glucose meter.

A study log or diary will be maintained to record daily health information, medication administration, and any symptoms or side effects experienced.

6 final assessment

At the end of the study period, a final assessment will be conducted. This includes a comprehensive evaluation of health changes, such as weight loss, waist circumference, and blood sugar control.

The results will contribute to understanding the efficacy and safety of maridebart cafraglutide in managing weight and diabetes.

Who Can Join the Study?

  • The participant must have given their agreement to join the study after understanding what it involves.
  • The participant must be at least 18 years old, or older if the legal age in their country is higher.
  • The participant must have a Body Mass Index (BMI) of 27 or higher. BMI is a measure that uses height and weight to estimate body fat.
  • The participant must have tried to lose weight at least once by diet and exercise but was not successful.
  • The participant must have been diagnosed with Type 2 Diabetes Mellitus (T2DM) at least 180 days before joining the study. This is based on guidelines from the World Health Organization (WHO).
  • The participant’s Hemoglobin A1c level, which is a measure of blood sugar levels over the past 2-3 months, must be between 7.0% and 10.0% at the time of joining the study.
  • The participant must be managing their Type 2 Diabetes Mellitus (T2DM) with diet and exercise alone, or with a stable treatment of up to 3 oral medications that lower blood sugar, for at least 90 days before joining the study. However, they should not be using certain medications called DPP-4 inhibitors or GLP-1RAs.
  • The participant must be considered by the study doctor to be well-motivated and willing to follow the study procedures, which include following lifestyle advice, keeping a study diary, attending required study visits, completing questionnaires, and checking their blood sugar levels as instructed.

Who Cannot Join the Study?

  • Patients with a history of severe heart disease cannot participate.
  • Individuals with uncontrolled high blood pressure are excluded. High blood pressure means the force of the blood against your artery walls is too high.
  • People with a history of certain types of cancer are not eligible.
  • Participants who have had surgery for weight loss in the past year cannot join.
  • Those with a history of drug or alcohol abuse in the past year are excluded.
  • Women who are pregnant or breastfeeding cannot participate.
  • Individuals currently participating in another clinical trial are not eligible.
  • Patients with a known allergy to the study medication or similar drugs cannot join.
  • People with certain mental health conditions that are not well controlled are excluded.
  • Individuals with severe liver or kidney disease cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD Pleven Bulgaria
Endokrinologikum Hamburg Hamburg Germany
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j. Ruda Slaska Poland
MVZ DiaMedicum Bad Mergentheim GmbH Bad Mergentheim Germany
NBR Polska Tomasz Klodawski Warsaw Poland
Diabeteszentrum Hamburg West Hamburg Germany
Universitaet Leipzig Leipzig Germany
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Diabetespraxis Dr. Braun Berlin Germany

Other Sites

Site Name City Country Status
SYNEXUS Magyarorszag Kft. Budapest Hungary
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
ResTrial s.r.o. Prague Czechia
Centro Cardiologico Monzino S.p.A. Milan Italy
ASST Fatebenefratelli Sacco Milan Italy
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Borbanya Praxis Egeszsegugyi Kft. Nyiregyhaza Hungary
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Ambenet GmbH Das Ambulante Behandlungsnetz Leipzig Germany
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
ARNAS Civico Di Cristina Benfratelli Palermo Italy
DRC Kft. Balatonfured Hungary
Milan Kvapil s.r.o. Příbram Czechia
Endokrinologie Cerny Most s.r.o. Prague Czechia
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Komaromi Selye Janos Korhaz Komarom Hungary
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Berlin Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
InnoDiab Forschung GmbH Essen Germany
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
University Of Debrecen Debrecen Hungary
University Teaching Hospital Markusovszky Szombathely Hungary
Clinexpert Kft. Budapest Hungary
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Pratia Pardubice a.s. Pardubice Czechia
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Klinische Forschung Berlin GbR Berlin Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Salvia Lekston I Madej Sp. J. Katowice Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne Swidnik Poland
Belinus Bt. Debrecen Hungary
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
ClinDiab Kft. Budapest Hungary
Diahelp s.r.o. Pardubice Czechia
Med-Tima Kft. Budapest Hungary
Mmdps Krphuq sornbr Prague Czechia
Efdifo Sky z omjw Lublin Poland
Ppwrlcilc 2tyj Mathw Stara Zagora Bulgaria
Inuzamkuc Ffp Camobrwc Adt Eibivkarzvnu Mmekxjfr Prague Czechia
Zwxnkgh fkg kcebsezxn Fdsefieuqf Dkc mvgf Lpklmgre Falkensee Germany
Pkslihr pwcozlps ou Dl Tiqpvxiswe Markkleeberg Germany
Miufmvl Cmxkti Bqwrmhgq Lztk Yambol Bulgaria
Pkhbuldoo Iczpxjhl Maaticwz Mrnrylbresiu Suobw Wrnmuebsquzr I Aaqvbraotxmon Warsaw Poland
Ldtwlhm Kaav Baja Hungary
Azxkgcx Uoovf Sviaqosyi Lptgok Dy Bwjixvy Bologna Italy
Cwo Sdvyneuehpcnfai Hipffwi Munich Germany
Cah Hfzdjcd Kraq Encs Hungary
Hqiwuukth &hdde Dooyxteofaqkmnzyftoddagrtb Hkzirhygpav Hohenmölsen Germany
Mtqbcnqi Szo z onac Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
27.05.2025
Czechia Czechia
Not recruiting
27.05.2025
Germany Germany
Not recruiting
27.05.2025
Hungary Hungary
Not recruiting
27.05.2025
Italy Italy
Not recruiting
27.05.2025
Poland Poland
Not recruiting
27.05.2025

Trial locations

Investigated drugs:

Maridebart Cafraglutide is a medication being studied for its potential to help people with type 2 diabetes who are also overweight or have obesity. This medication is designed to help reduce body weight. It works by mimicking a hormone in the body that helps regulate appetite and food intake, which may lead to weight loss. The goal of using this medication in the trial is to see if it can effectively help participants lose weight compared to those who do not receive the medication. The study aims to evaluate how safe and well-tolerated this medication is for the participants.

Investigated diseases:

Obesity – Obesity is a chronic condition characterized by an excessive accumulation of body fat. It develops when there is an imbalance between calorie intake and energy expenditure, leading to weight gain. Over time, this condition can result in increased body mass index (BMI) and changes in body composition. As obesity progresses, it can affect various bodily functions and contribute to the development of other health issues. The condition often leads to increased waist circumference and can impact metabolic processes. Obesity is a significant risk factor for various diseases, including type 2 diabetes and cardiovascular disorders.

Trial ID:
2024-515523-11-00
Protocol code:
20210184
NCT ID:
NCT06858878
Trial Phase:
Therapeutic confirmatory (Phase III)

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