---
title: A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
nct_id: NCT06660173
overall_status: ACTIVE_NOT_RECRUITING
phase: PHASE2
sponsor: Amgen
study_type: INTERVENTIONAL
primary_condition: Type 2 Diabetes Mellitus (T2DM)
countries: United States, Austria, Greece, Hong Kong, Hungary, Italy, Japan, Poland, Puerto Rico, Romania, South Korea, Spain, Sweden, Taiwan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06660173.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06660173"
ct_last_update_post_date: 2025-11-25
last_seen_at: "2026-05-12T07:05:01.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)

**Official Title:** A Study to Evaluate the Efficacy, Safety & Tolerability of Maridebart Cafraglutide in Adults With T2DM

**NCT ID:** [NCT06660173](https://clinicaltrials.gov/study/NCT06660173)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 409
- **Lead Sponsor:** Amgen
- **Conditions:** Type 2 Diabetes Mellitus (T2DM)
- **Start Date:** 2024-11-07
- **Completion Date:** 2026-11-10
- **CT.gov Last Update:** 2025-11-25

## Brief Summary

The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)
* Type 2 diabetes for ≥6 months according to the World Health Organization classification
* HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory
* Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening
* Body mass index of 23 to 50 kilograms per square meter

Exclusion Criteria:

* Type 1 diabetes
* Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening
* Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
* History of acute or chronic pancreatitis
* Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
* Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure.
* Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.
```

## Arms

- **Maridebart Cafraglutide** (EXPERIMENTAL) — Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.
- **Placebo** (PLACEBO_COMPARATOR) — Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.

## Interventions

- **Maridebart Cafraglutide** (DRUG) — Solution for subcutaneous injection.
- **Placebo** (DRUG) — Solution for subcutaneous injection.

## Primary Outcomes

- **Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)** _(time frame: Baseline to Week 24)_

## Secondary Outcomes

- **Percent Change From Baseline to Week 24 in Body Weight** _(time frame: Baseline to Week 24)_
- **Number of Participants Achieving HbA1c < 7.0% at Week 24** _(time frame: Week 24)_
- **Number of Participants Achieving HbA1c ≤ 6.5% at Week 24** _(time frame: Week 24)_
- **Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24** _(time frame: Week 24)_
- **Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24** _(time frame: Week 24)_
- **Change From Baseline to Week 24 in Fasting Glucose** _(time frame: Baseline to Week 24)_
- **Percent Change From Baseline to Week 24 in Total Cholesterol** _(time frame: Baseline to Week 24)_
- **Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C)** _(time frame: Baseline to Week 24)_
- **Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C)** _(time frame: Baseline to Week 24)_
- **Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C)** _(time frame: Baseline to Week 24)_
- **Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C)** _(time frame: Baseline to Week 24)_
- **Percent Change From Baseline to Week 24 in Triglycerides** _(time frame: Baseline to Week 24)_
- **Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA)** _(time frame: Baseline and Week 24)_
- **Change From Baseline to Week 24 in Systolic Blood Pressure** _(time frame: Baseline and Week 24)_
- **Change From Baseline to Week 24 in Diastolic Blood Pressure** _(time frame: Baseline and Week 24)_
- **Change from Baseline to Week 24 in High-sensitivity C-reactive Protein** _(time frame: Baseline and Week 24)_
- **Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20** _(time frame: Week 20)_
- **Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20** _(time frame: Week 20)_
- **Number of Participants with Treatment Emergent Adverse Events** _(time frame: Up to 24 Weeks)_
- **Number of Participants with Serious Adverse Events** _(time frame: Up to 24 Weeks)_
- **Number of Participants with Anti-maridebart Cafraglutide Antibody Formation** _(time frame: Up to Week 24)_

## Locations (96)

- Accel Research Site - Birmingham Clinical Research Unit, Birmingham, Alabama, United States
- Anaheim Clinical Trials, Anaheim, California, United States
- Hope Clinical Research LLC, Canoga Park, California, United States
- Orange County Research Center, Lake Forest, California, United States
- San Jose Clinical Trials, San Jose, California, United States
- Northeast Research Institute - Neri, Fleming Island, Florida, United States
- New Horizon Research Center, Miami, Florida, United States
- Florida Institute for Clinical Research, Orlando, Florida, United States
- Conquest Research - Winter Park, Winter Park, Florida, United States
- Accel Research Site - Neurostudies, Decatur, Georgia, United States
- Cedar Crosse Research and Health Care, Chicago, Illinois, United States
- Tandem Clinical Research - Marrero, Marrero, Louisiana, United States
- DM Clinical - Detroit, Southfield, Michigan, United States
- Montana Medical Research, Missoula, Montana, United States
- Physicians East, Greenville, North Carolina, United States
- Diabetes and Endocrinology Associates of Stark County Inc, Canton, Ohio, United States
- Alliance for Multispecialty Research, Norman, Oklahoma, United States
- Trial Management Associates - Myrtle Beach, Myrtle Beach, South Carolina, United States
- FutureSearch Trials of Neurology, Austin, Texas, United States
- Velocity Clinical Research - Dallas, Dallas, Texas, United States
- DM Clinical Research - Cyfair Clinical Research Center, Houston, Texas, United States
- Southern Endocrinology Associates PA, Mesquite, Texas, United States
- Be Well Clinical Studies, Round Rock, Texas, United States
- Diabetes and Glandular Disease Clinic, San Antonio, Texas, United States
- DM Clinical Research - Martin Diagnostic Clinic, Tomball, Texas, United States
- Charlottesville Medical Research Center, Charlottesville, Virginia, United States
- Manassas Clinical Research Center Inc, Manassas, Virginia, United States
- Eastside Research Associates Health Research, Redmond, Washington, United States
- Medizinische Universitaet Graz, Graz, Austria
- Krankenhaus der Barmherzigen Brueder Linz, Linz, Austria
- Universitaetsklinikum Allgemeines Krankenhaus Wien, Vienna, Austria
- Klinik Hietzing, Vienna, Austria
- Laiko General Hospital of Athens, Athens, Greece
- Athens Medical Center S.A - Iatriko Amarousiou, Marousi, Greece
- Athens Medical Center- Iatriko Paleou Falirou, Palaió Fáliro, Greece
- Geniko Nosokomeio Peiraia Tzaneio, Piraeus, Greece
- General Hospital of Thessaloniki Ahepa, Thessaloniki, Greece
- Thermi Clinic S.A., Thessaloniki, Greece
- Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong
- Lausmed Kft, Baja, Hungary
- Drug Research Center Kft, Balatonfüred, Hungary
- Szent Margit Rendelointezet Diabetologiai Ambulancia, Budapest, Hungary
- Clinexpert Kft, Budapest, Hungary
- Obudai Egeszsegugyi Centrum Kft, Budapest, Hungary
- Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft, Budapest, Hungary
- Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary
- CRU Hungary Kft, Encs, Hungary
- Borbanya Praxis Egeszsegugyi Kft, Nyíregyháza, Hungary
- Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft, Zalaegerszeg, Hungary
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari, Bari, Italy
- IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola, Bologna, Italy
- Universita degli Studi Gabriele D Annunzio di Chieti e Pescara, Chieti, Italy
- IRCCS Ospedale San Raffaele, Milan, Italy
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan, Italy
- Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco, Milan, Italy
- Kunisaki Makoto Clinic, Fukuoka, Fukuoka, Japan
- Nakamoto Medical Clinic, Mito, Ibaraki, Japan
- Ohishi Naika Clinic, Tsuchiura-shi, Ibaraki, Japan
- Morinaga Ueno Clinic, Kumamoto, Kumamoto, Japan
- Midori Clinic, Nagasaki, Nagasaki, Japan
- Shiraiwa Medical Clinic, Kashiwara-shi, Osaka, Japan
- Plumeria DM Clinic, Shizuoka, Shizuoka, Japan
- Yutenji Medical Clinic, Meguro-ku, Tokyo, Japan
- Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska, Bialystok, Poland
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow, Poland
- Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii, Lublin, Poland
- Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna, Staszów, Poland
- Nbr Polska Tomasz Klodawski, Warsaw, Poland
- Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska, Wroclaw, Poland
- Futuremeds spolka z ograniczona odpowiedzialnoscia, Wroclaw, Poland
- Latin Clinical Trial Center, San Juan, Puerto Rico
- Mariodiab Clinic SRL, Brasov, Romania
- Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL, Bucharest, Romania
- Institutul National de Diabet si Nutritie si Boli Metabolice N C Paulescu, Bucharest, Romania
- Consultmed SRL, Iași, Romania
- Clinica Korall, Satu Mare, Romania
- Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea
- Seoul National University Hospital, Seoul, South Korea
- Kangbuk Samsung Hospital, Seoul, South Korea
- Severance Hospital Yonsei University Health System, Seoul, South Korea
- Asan Medical Center, Seoul, South Korea
- The Catholic University of Korea Seoul St Marys Hospital, Seoul, South Korea
- Hospital Vithas Sevilla, Castilleja de la Cuesta, Andalusia, Spain
- Hospital Clinico Universitario Virgen de la Victoria, Málaga, Andalusia, Spain
- Hospital Universitario Arnau de Vilanova Lleida, Lleida, Catalonia, Spain
- Complexo Hospitalario Universitario A Coruña, A Coruña, Galicia, Spain
- Hospital Universitario de La Ribera, Alzira, Valencia, Spain
- Ostra Sjukhuset, Gothenburg, Sweden
- Skanes universitetssjukhus, Lund, Sweden
- Universitetssjukhuset Orebro, Örebro, Sweden
- Sabbatsbergs Sjukhus, Stockholm, Sweden
- Sodersjukhuset, Stockholm, Sweden
- Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan
- National Cheng Kung University Hospital, Tainan, Taiwan
- National Taiwan University Hospital, Taipei, Taiwan
- Taipei Veterans General Hospital, Taipei, Taiwan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.accel research site - birmingham clinical research unit|birmingham|alabama|united states` — added _(2026-05-12)_
- `locations.anaheim clinical trials|anaheim|california|united states` — added _(2026-05-12)_
- `locations.hope clinical research llc|canoga park|california|united states` — added _(2026-05-12)_
- `locations.orange county research center|lake forest|california|united states` — added _(2026-05-12)_
- `locations.san jose clinical trials|san jose|california|united states` — added _(2026-05-12)_
- `locations.northeast research institute - neri|fleming island|florida|united states` — added _(2026-05-12)_
- `locations.new horizon research center|miami|florida|united states` — added _(2026-05-12)_
- `locations.florida institute for clinical research|orlando|florida|united states` — added _(2026-05-12)_
- `locations.conquest research - winter park|winter park|florida|united states` — added _(2026-05-12)_
- `locations.accel research site - neurostudies|decatur|georgia|united states` — added _(2026-05-12)_
- `locations.cedar crosse research and health care|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.tandem clinical research - marrero|marrero|louisiana|united states` — added _(2026-05-12)_
- `locations.dm clinical - detroit|southfield|michigan|united states` — added _(2026-05-12)_
- `locations.montana medical research|missoula|montana|united states` — added _(2026-05-12)_
- `locations.physicians east|greenville|north carolina|united states` — added _(2026-05-12)_
- `locations.diabetes and endocrinology associates of stark county inc|canton|ohio|united states` — added _(2026-05-12)_
- `locations.alliance for multispecialty research|norman|oklahoma|united states` — added _(2026-05-12)_
- `locations.trial management associates - myrtle beach|myrtle beach|south carolina|united states` — added _(2026-05-12)_
- `locations.futuresearch trials of neurology|austin|texas|united states` — added _(2026-05-12)_
- `locations.velocity clinical research - dallas|dallas|texas|united states` — added _(2026-05-12)_
- `locations.dm clinical research - cyfair clinical research center|houston|texas|united states` — added _(2026-05-12)_
- `locations.southern endocrinology associates pa|mesquite|texas|united states` — added _(2026-05-12)_
- `locations.be well clinical studies|round rock|texas|united states` — added _(2026-05-12)_
- `locations.diabetes and glandular disease clinic|san antonio|texas|united states` — added _(2026-05-12)_
- `locations.dm clinical research - martin diagnostic clinic|tomball|texas|united states` — added _(2026-05-12)_
- `locations.charlottesville medical research center|charlottesville|virginia|united states` — added _(2026-05-12)_
- `locations.manassas clinical research center inc|manassas|virginia|united states` — added _(2026-05-12)_
- `locations.eastside research associates health research|redmond|washington|united states` — added _(2026-05-12)_
- `locations.medizinische universitaet graz|graz||austria` — added _(2026-05-12)_
- `locations.krankenhaus der barmherzigen brueder linz|linz||austria` — added _(2026-05-12)_
- `locations.universitaetsklinikum allgemeines krankenhaus wien|vienna||austria` — added _(2026-05-12)_
- `locations.klinik hietzing|vienna||austria` — added _(2026-05-12)_
- `locations.laiko general hospital of athens|athens||greece` — added _(2026-05-12)_
- `locations.athens medical center s.a - iatriko amarousiou|marousi||greece` — added _(2026-05-12)_
- `locations.athens medical center- iatriko paleou falirou|palaió fáliro||greece` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06660173.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06660173*  
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