AzTrials
AzTrials

ObesityPhase 2NCT05669599

Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

A Phase 2 study testing Maridebart Cafraglutide in people with Obesity and Overweight, run by Amgen at 78 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Obesity, Overweight, Type 2 Diabetes Mellitus
What is being tested?
Maridebart Cafraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
592 participants
Where
78 sitesin 12 countries
Study dates
18 Jan 2023to 16 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years at the time of signing informed consent.
  • BMI ≥30 kg/m^2, or ≥27 kg/m^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease.
  • For participants in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label.
  • History of at least one unsuccessful dietary effort to lose body weight.

Who cannot join

  • Change in body weight greater than 5 kg within 3 months prior to screening.
  • Obesity induced by other endocrinologic disorders.
  • History of pancreatitis.
  • Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
  • History of major depressive disorder within the last 2 years.
  • Any lifetime history of other major psychiatric disorder or suicide attempt.

Trial locations and contacts

78 sites in 12 countries.

78 sites in 12 countries

United States29 sites

  • Research Innovations LLC dba Internal Medicine Care Inc

    Beavercreek, Ohio, 45431

  • PanAmerican Clinical Research LLC

    Brownsville, Texas, 78520

  • Headlands Research Brownsville

    Brownsville, Texas, 78526

  • University of Chicago

    Chicago, Illinois, 60637

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Alliance for Multispecialty Research Miami

    Coral Gables, Florida, 33134

  • Medical Care LLC

    Elizabethton, Tennessee, 37643

  • East-West Medical Research

    Honolulu, Hawaii, 96814

  • Alliance for Multispecialty Research Kansas City

    Kansas City, Missouri, 64114

  • Ark Clinical Research- Long Beach

    Long Beach, California, 90815

  • Louisville Metabolic and Atherosclerosis Research Center

    Louisville, Kentucky, 40213

  • Tandem Clinical Research - Marrero

    Marrero, Louisiana, 70072

  • Alliance for Multispecialty Research Mobile

    Mobile, Alabama, 36608

  • Lucas Research

    Morehead City, North Carolina, 28557

  • Alliance for Multispecialty Research Newton

    Newton, Kansas, 67114

  • Alliance for Multispecialty Research Norman

    Norman, Oklahoma, 73069

  • Foothills Research Center

    Phoenix, Arizona, 85044

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Diabetes and Glandular Disease Clinic

    San Antonio, Texas, 78229

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • Texas Diabetes Institute

    San Antonio, Texas, 78284

  • HonorHealth

    Scottsdale, Arizona, 85258

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Ark Clinical Research- Tustin

    Tustin, California, 92780

  • Orange County Research Center

    Tustin, California, 92780

  • Diablo Clinical Research

    Walnut Creek, California, 94598

Other trials in United States

Japan9 sites

  • Mazda Hospital of Mazda Motor Corporation

    Aki-gun, Hiroshima, 735-8585

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo, 103-0025

  • Wellness Tenjin Clinic

    Fukuoka, Fukuoka, 810-0001

  • Matsunami Health Promotion Clinic

    Hashima-gun, Gifu, 501-6061

  • Shiraiwa Medical Clinic

    Kashiwara-shi, Osaka, 582-0005

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, Ehime, 790-0034

  • Nakakinen Clinic

    Naka, Ibaraki, 311-0113

  • Nishiyamado Keiwa Hospital

    Naka, Ibaraki, 311-0133

  • MIH Clinic Yoyogi

    Shibuya-ku, Tokyo, 151-0051

Other trials in Japan

Australia6 sites

  • Clinical Medical and Analytical eXellence CMAX

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital (RPAH) Clinic

    Camperdown, New South Wales, 2006

  • Monash Medical Centre

    Clayton, Victoria, 3146

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Austin Health, Heidelberg Repatriation Hospital

    Heidelberg Heights, Victoria, 3081

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004

Other trials in Australia

Poland6 sites

  • AthleticoMed

    Bydgoszcz, 85-752

  • Centrum Badan Klinicznych PI-House Spzoo

    Gdansk, 80-546

  • Centrum Terapii Wspolczesnej

    Lodz, 90-338

  • AppleTreeClinics Network Spzoo

    Lodz, 90-349

  • Clinical Best Solutions Sp zoo Spolka Komandytowa

    Lublin, 20-078

  • Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, 52-210

Other trials in Poland

Canada5 sites

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • University of Calgary

    Calgary, Alberta, T2T 5C7

  • Centricity Research Vaughan Endocrinology

    Concord, Ontario, L4K 4M2

  • Institut Universitaire de cardiologie et de pneumologie de Quebec

    Québec, Quebec, G1V 4G5

  • Clinique des Maladies Lipidiques de Quebec Incorporated

    Québec, Quebec, G1V 4W2

Other trials in Canada

Hungary4 sites

  • Budapesti Szent Ferenc Korhaz

    Budapest, 1021

  • Clinexpert Kft

    Budapest, 1033

  • CRU Hungary Kft

    Encs, 3860

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

Other trials in Hungary

South Korea4 sites

  • Dongguk University Ilsan Hospital

    Goyang-si, Gyeonggi-do, 10326

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Kangbuk Samsung Hospital

    Seoul, 03181

Other trials in South Korea

Spain4 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia, 15006

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, Andalusia, 41950

  • Hospital Universitario Arnau de Vilanova Lleida

    Lleida, Catalonia, 25198

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

Other trials in Spain

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Czechia3 sites

  • Endokrinologicky ustav

    Prague, 116 94

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Institut klinicke a experimentalni mediciny

    Prague, 140 21

Other trials in Czechia

Germany3 sites

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117

  • Diabeteszentrum Hamburg West

    Hamburg, 22607

  • Universitaetsmedizin Leipzig

    Leipzig, 04103

Other trials in Germany

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

About this study

Official title: A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).

Being tested
Maridebart Cafraglutide, Placebo
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maridebart CafraglutideBiological

    Also called AMG 133

    Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.

  • PlaceboDrug

    Participants will receive placebo by SC injection.

Study groups in NCT05669599
Study groupRoleWhat they receive
Cohort A: Maridebart CafraglutideExperimentalPart 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Receives: Biological: Maridebart Cafraglutide; Drug: Placebo
Cohort A: PlaceboPlacebo comparatorPart 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts . Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Receives: Biological: Maridebart Cafraglutide; Drug: Placebo
Cohort B: Maridebart CafraglutideExperimentalPart 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Receives: Biological: Maridebart Cafraglutide; Drug: Placebo
Cohort B: PlaceboPlacebo comparatorPart 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Receives: Biological: Maridebart Cafraglutide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline to Week 52 in Body Weight

    Measured: Baseline and Week 52

Secondary outcomes (26)

  1. Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52

    Measured: Baseline and Week 52

  2. Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52

    Measured: Baseline and Week 52

  3. Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52

    Measured: Baseline and Week 52

  4. Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52

    Measured: Baseline and Week 52

  5. Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)

    Measured: Baseline and Week 52

  6. Change from Baseline to Week 52 in Fasting Serum Insulin

    Measured: Baseline and Week 52

  7. Change from Baseline to Week 52 in Fasting Plasma Glucose

    Measured: Baseline and Week 52

  8. Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)

    Measured: Baseline and Week 52

  9. Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)

    Measured: Baseline and Week 52

  10. Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide

    Measured: Up to Week 64

  11. Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide

    Measured: Up to Week 64

  12. Change from Baseline to Week 52 in Waist Circumference

    Measured: Baseline and Week 52

  13. Change from Baseline to Week 52 in Body Weight

    Measured: Baseline and Week 52

  14. Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)

    Measured: Baseline and Week 52

  15. Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)

    Measured: Baseline and Week 52

  16. Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA)

    Analyzed in a subset of participants.

    Measured: Baseline and Week 52

  17. Change from Baseline to Week 52 in Lean Body Mass Using DEXA

    Analyzed in a subset of participants.

    Measured: Baseline and Week 52

  18. Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)

    Measured: Baseline and Week 52

  19. Change from Baseline to Week 52 in Body Mass Index (BMI)

    Measured: Baseline and Week 52

  20. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

    Measured: Baseline and Week 52

  21. Percent Change From Baseline in Total Cholesterol

    Measured: Baseline and Week 52

  22. Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

    Measured: Baseline and Week 52

  23. Percent Change From Baseline in non-HDL-C

    Measured: Baseline and Week 52

  24. Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)

    Measured: Baseline and Week 52

  25. Percent Change From Baseline in Triglycerides

    Measured: Baseline and Week 52

  26. Percent Change From Baseline in Free Fatty Acids (FFA)

    Measured: Baseline and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2023
  2. Study start18 Jan 2023
  3. Primary completion8 Oct 2024
  4. Study completion16 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
592 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05669599
Sponsor's protocol ID
20190218
Other IDs
2023-510470-13-00, 2023
Status last verified
Jan 2026
First submitted
20 Dec 2022
Last updated
20 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Jastreboff AM, Ryan DH, Bays HE, Ebeling PR, Mackowski MG, Philipose N, Ross L, Liu Y, Burns CE, Abbasi SA, Pannacciulli N; MariTide Phase 2 Obesity Trial Investigators. Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity - A Phase 2 Trial. N Engl J Med. 2025 Sep 4;393(9):843-857. doi: 10.1056/NEJMoa2504214. Epub 2025 Jun 23.

    PubMed 40549887

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Maridebart Cafraglutide in people with Obesity and Overweight, run by Amgen at 78 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Japan, Australia, Poland, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to Week 52 in Body Weight (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05669599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in