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Long‑term Efficacy, Safety and Tolerability of maridebart cafraglutide in Adults with Obesity and Type 2 Diabetes

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What is this study about?

The study focuses on adults who have obesity or are overweight and also have Type 2 Diabetes Mellitus. Participants will receive a once‑weekly injection under the skin (subcutaneous use) of the investigational medicine maridebart cafraglutide or a matching placebo. The medication is given as a clear liquid that is injected with a small needle.

The main aim of the trial is to see how the medicine affects body weight over a long period and to evaluate its safety and how well it is tolerated. After enrollment, participants will attend regular clinic visits where the injection is given, vital signs are checked, and blood samples are taken. The study continues for several months, allowing researchers to track changes in weight and health over time.

Safety is closely monitored, and any side effects or problems are recorded. In addition to weight, the study measures a blood test called HbA1c, which reflects average blood sugar levels, to understand the impact on diabetes control. Participants also complete questionnaires about how weight changes affect daily activities and overall quality of life.

1 enrollment and study identification

after you have given informed consent, you receive a unique study identification number that will be used for all trial activities.

2 baseline assessments

during the first visit, clinical staff measure your body weight, waist circumference, and blood sugar level (hbA1c, a test that shows average blood sugar over the past few months).

you also complete a questionnaire about how your weight affects daily activities.

3 randomization to treatment

based on a computer‑generated schedule, you are randomly assigned to receive either maridebart cafraglutide (the investigational drug) or a matching placebo. the assignment is double‑blind, meaning you and the study staff do not know which product you receive.

4 medication administration

you receive a subcutaneous injection (injection under the skin) of the assigned product at each scheduled visit.

the injection is a solution for injection; the exact dose is defined by the study protocol (listed as 0 mg in the product information, indicating the dose is determined by the trial).

injections are given according to the study schedule, which continues for the duration of the extension trial.

5 regular follow‑up visits

at each follow‑up visit you undergo repeat measurements of body weight, waist circumference, and hbA1c.

you answer questions about any side effects or health changes since the previous visit.

the frequency of visits follows the trial schedule, typically occurring every few weeks throughout the study period.

6 safety monitoring

clinical staff review any adverse events (undesired health changes) you report and assess their seriousness.

this monitoring continues at every visit to ensure your safety while you remain in the trial.

7 study duration

the extension trial is planned to run until the overall study end date of 2028‑03‑17.

your participation continues for the full length of the trial unless you withdraw earlier or are discontinued for safety reasons.

8 final assessment and study completion

at the last scheduled visit, you undergo the same set of measurements performed at baseline, including body weight, waist circumference, hbA1c, and quality‑of‑life questionnaire.

after these final assessments, the trial is concluded for you and you are informed of the study completion.

Who Can Join the Study?

  • You must sign an informed consent form, which means you agree to join the study and understand the rules and requirements.
  • You must have finished the earlier study called the parent trial and you must not have stopped the study medication permanently.
  • You must have been placed into a treatment group, a process known as randomized, within 7 days after the week‑72 visit of the parent trial.
  • You must use the birth‑control method required by the study, called protocol‑specified contraception, while taking the study drug and for 16 weeks after your last dose.
  • You can be either male or female, must be a patient, and must be within the age range set by the study.

Who Cannot Join the Study?

  • Planned surgical, endoscopic, or device‑based treatment for obesity during the study period.
  • Any other serious health problem (such as drug or alcohol abuse, eating disorders, or other conditions) that the doctor thinks could be unsafe for you.
  • Currently pregnant, breastfeeding, or planning to become pregnant or breastfeed while in the study and for 16 weeks after the last dose.
  • Major surgical procedure planned during the study.
  • Minor surgery that does not require general anesthesia may be allowed, but only if the doctor decides it is safe.
  • People who work on the study or their immediate family members (spouse, parent, child, or sibling) cannot take part.
  • Body mass index (BMI) ≤ 18.5 kg/m² (considered underweight).
  • Known allergy or sensitivity to any of the study medication or its ingredients.
  • History of ischemic optic neuropathy (damage to the eye’s optic nerve caused by reduced blood flow).
  • Any cancer diagnosed during the earlier trial, except for certain early‑stage skin cancers and early‑stage breast, cervical, or prostate cancers that have been treated with the goal of cure.
  • Newly identified multiple endocrine neoplasia syndrome type 2 or a first‑degree relative (parent, sibling, or child) with medullary thyroid carcinoma (a specific type of thyroid cancer).
  • PHQ‑9 score ≥ 15 at the week‑72 visit (a questionnaire that measures the severity of depression).
  • Severe suicidal thoughts (category 4 or 5) or any suicidal behavior on the Columbia‑Suicide Severity Rating Scale (C‑SSRS) at the week‑72 visit.
  • If the doctor believes you are unlikely to complete all required study visits, procedures, and restrictions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diabeteszentrum Hamburg West Hamburg Germany
Azienda Ospedaliero Universitaria Careggi Florence Italy
MVZ DiaMedicum Bad Mergentheim GmbH Bad Mergentheim Germany
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j. Ruda Slaska Poland
Diabetespraxis Dr. Braun Berlin Germany
Praxis für Kardiologie Markkleeberg Germany
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD Pleven Bulgaria
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria

Other Sites

Site Name City Country Status
Clinexpert Kft. Budapest Hungary
Tomasz Blicharski Lubelskie Centrum Diagnostyczne Swidnik Poland
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Borvo Clinic Kft. Debrecen Hungary
Diabetes Schwerpunktpraxis Falkensee Germany
CDG Studienambulanz Dr. Hartard Munich Germany
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
NBR POLSKA TOMASZ KŁODAWSKI Warsaw Poland
Uxzhvyocbf Oq Dlptvoss Debrecen Hungary
Uzvyycsawu Tplfqqah Hiouugea Mjgkzolcvthm Szombathely Hungary
Vvtzanwg Cfukafgp Rzululxk Lqblaxz Gxpq Luebeck Germany
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Esiokziqucfulv Cpjra Mwav sgwuvj Prague Czechia
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Emugdn Shf z oqiu Lublin Poland
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Rbwmgbzo suemqg Prague Czechia
Oxqtif Eyhjqcmwuqmzu Caxmzaz Kjwq Dunaújváros Hungary
Pwrdut Pwcpkfllg auzc Pardubice Czechia
Iponzqsm fevs Ddwirrmbzrdwzmdph Mchbxvnh Glra Munster Germany
Dxakxqp supyui Pardubice Czechia
Cklgkrzh Kkil Budapest Hungary
Fcdrnacr Nulumwzbu Bmdo Brno Czechia
Fdcbgbag Nktaroubq Kkyeahzpp Vwumxzwfu Prague Czechia
Pdohzkyql Isksobyf Mxjsjmsc Mrgkfvlpcpzg Srjsn Wuqrqgcbxhjs I Aikxznmddbkun Warsaw Poland
Lmelled Kjzf Baja Hungary
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Vgjtdzfje Fghavthd Npgytkodn V Pzgmb Prague Czechia
Adjbxpy Ubbzl Schgfankb Llahxi Dj Bqxoatd Bologna Italy
Swntom Lcejwzb I Mehpk Srm Jn Katowice Poland
Cxlnng Cnwvfdczqfuw Mmxeatd Slbdul Milan Italy
Ambd Fwbhvtzfxflwymek Srfmi Milan Italy
Ihmwupnci Fkv Ctbsuxzc Auw Euqkctvrphxf Mjgipxrc Prague Czechia
Haii Ujo Duouuuhuesgnlkv Nua Bjq Oqvdkytbza Uhhcqmvzzinzgxtbrgp Diw Rkwrcvikfmsjqwcqy Bjrxtp Bad Oeynhausen Germany
Wfkoknfpr I Bytpsvlk A Ssbucgurmjho stqr Wroclaw Poland
Idtoejta Fmfpfslnv Gqzi Essen Germany
Rngxjp Ivsntmee fyyj maspnddjayaf Sbspwzz umh Fqywrynevcj Gwnl Oldenburg In Holstein Germany
Bovbtxzl Pprtlb Epliuviteutl Kift Nyiregyhaza Hungary
Cyycxbbo Bfbi Sefhfhgjg Svu z oftl Szrf Lublin Poland
Aqtslfn Gfeh Dbx Aqrbjhdxy Baxelztvcqoicmy Leipzig Germany
Crn Omgoswj srlmvm Moravska Ostrava A Privoz Czechia
Cruauxk Ttfuvjk Wrwywdmvqkgo Jeeo Jnzfmcbbrwfx Sfwkyw Lodz Poland
Dox Kqja Balatonfured Hungary
Mrqwswhvcufsc Vzrtbtvhofgiqdghln Au Bmpxwpq Sbxnlca Gbo Berlin Germany
Mjjlssai Kesf Budapest Hungary
Mnbiyfgu Srb z omfv Oświęcim Poland
Dsrvnwewqseckdw Sspyypplatyjxstfw Hotdvpsxbqqkeztpbdqyyvof Hohenmölsen Germany
Mqgncky Cftrrg Bxpgelzh Lbsz Yambol Bulgaria
Pkagizlbi 2xgy Mryrt Stara Zagora Bulgaria

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
13.10.2026
Czechia Czechia
Not yet recruiting
13.10.2026
Germany Germany
Not yet recruiting
13.10.2026
Hungary Hungary
Not yet recruiting
13.10.2026
Italy Italy
Not yet recruiting
13.10.2026
Poland Poland
Not yet recruiting
13.10.2026

Trial locations

Investigated Drugs:

AMG 133 is the investigational drug being studied in this trial. It contains the active ingredient maridebart cafraglutide and is given as a liquid that is injected under the skin. The purpose of using AMG 133 is to see if it can help people who are overweight or have obesity and also have type 2 diabetes lose weight over a long period, while also checking that it is safe and well‑tolerated.

Investigated Diseases:

Obesity – Obesity is a chronic condition characterized by excess body fat, usually defined by a body‑mass index of 30 kg/m² or higher. It develops when energy intake consistently exceeds energy expenditure, leading to gradual accumulation of adipose tissue. Over time the amount of stored fat can increase, making weight loss more difficult and the condition more entrenched. The body’s metabolism and appetite signals may adapt, further promoting weight gain. Without effective changes, the excess weight tends to persist or progress.

Trial ID:
2025-524788-19-00
Protocol code:
20210182
Trial Phase:
Therapeutic confirmatory (Phase III)

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