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Type 2 Diabetes Mellitus (T2DM), Obesity, OverweightPhase 3MARITIME-2NCT06858878

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

A Phase 3 study testing Maridebart cafraglutide in people with Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, run by Amgen at 187 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight. Read more about this study

Who is it for?
Ages 18 to 99 years
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
1,105 participants
Where
187 sitesin 13 countries
Study dates
17 Mar 2025to 16 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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.
  • Body mass index ≥ 27 kg/m^2.
  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  • Diagnosis of T2DM.

Who cannot join

  • Type 1 diabetes mellitus.
  • Self-reported change in body weight > 5 kg within 90 days before screening.
  • Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
  • Obesity induced by other endocrinologic disorders.
  • Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
  • History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
  • History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
  • Lifetime history of suicide attempt.

Trial locations and contacts

187 sites in 13 countries.

187 sites in 13 countries

United States59 sites

  • Albany Medical College

    Albany, New York, 12203

  • Annapolis Internal Medicine, LLC

    Annapolis, Maryland, 21401

  • Asheville Clinical Research

    Asheville, North Carolina, 28803

  • Elligo Clinical Research Center

    Austin, Texas, 78701

  • Velocity Clinical Research - Cincinnati

    Blue Ash, Ohio, 45242

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • San Fernando Valley Health Institute

    Canoga Park, California, 91304

  • Core Healthcare Group

    Cerritos, California, 90703

  • Velocity Clinical Research Chula Vista

    Chula Vista, California, 91911

  • Velocity Clinical Research - Springdale

    Cincinnati, Ohio, 45246

  • Osvaldo A Brusco MD PA

    Corpus Christi, Texas, 78414

  • Cedar Health Research, LLC

    Dallas, Texas, 75251

  • Soma Clinical Trials, LLC

    Denison, Texas, 75020

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

  • Medical Care LLC

    Elizabethton, Tennessee, 37643

  • Headlands Research California

    Escondido, California, 92025

  • Cedar Health Research, LLC

    Euless, Texas, 76040

  • Gilbert Center for Family Medicine

    Gilbert, Arizona, 85296

  • Physicians East

    Greenville, North Carolina, 27834

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • Juno Research LLC

    Houston, Texas, 77040

  • Juno Research LLC

    Houston, Texas, 77054

  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri, 64114

  • Palm Research Center Inc

    Las Vegas, Nevada, 89128

  • Alliance for Multispecialty Research - Layton

    Layton, Utah, 84041

  • Manassas Clinical Research Center Inc

    Manassas, Virginia, 20110

  • Tekton Research

    McKinney, Texas, 75069

  • Indiana Medical Research Institute

    Merrillville, Indiana, 46410

  • Desert Clinical Research

    Mesa, Arizona, 85213

  • Optimus U Corporation

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33165

  • San Marcus Research Clinic Inc

    Miami Lakes, Florida, 33014

  • International Diabetes Center - HealthPartners Institute

    Minneapolis, Minnesota, 55416

  • Alliance for Multispecialty Research Mobile

    Mobile, Alabama, 36608

  • Paradigm Clinical Research

    Modesto, California, 95355

  • Ima Clinical Research- Monroe

    Monroe, Louisiana, 71201

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • West Clinical Research

    Morehead City, North Carolina, 28557

  • Ima Clinical Research - West Virginia

    Morgantown, West Virginia, 26505

  • Alliance for Multispecialty Research Newton

    Newton, Kansas, 67114

  • Flourish Research

    Northridge, California, 91325

  • Alliance For Multispecialty Research - Oak Brook

    Oak Brook, Illinois, 60523

  • University of California Irvine

    Orange, California, 92868

  • Florida Institute for Clinical Research

    Orlando, Florida, 32825

  • Advanced Internal Medicine

    Paducah, Kentucky, 42001

  • Alliance for Multispecialty Research, LLC - Park Ridge

    Park Ridge, Illinois, 66068

  • Avacare Foothills Research Center

    Phoenix, Arizona, 85044

  • Empire Clinical Research

    Pomona, California, 91767

  • Greenwich Clinical Trials

    Riverside, Connecticut, 06878

  • Northeast Clinical Research of San Antonio LLC

    San Antonio, Texas, 78233

  • Infinity Clinical Trials

    San Diego, California, 92108

  • VA Puget Sound Healthcare System

    Seattle, Washington, 98108

  • Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie

    Skokie, Illinois, 60077

  • Vector Clinical Trials

    Sparks, Nevada, 89436

  • Premier Research

    Trenton, New Jersey, 08611

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50266

  • Encore Medical Research of Weston LLC

    Weston, Florida, 33331

  • Alliance for Multispecialty Research LLC

    Wichita, Kansas, 67207

  • Conquest Research - Winter Park

    Winter Park, Florida, 32789

Other trials in United States

Germany20 sites

  • Universitatsklinikum Aachen

    Aachen, 52074

  • Universitaets-Herzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, 79189

  • Diabetespraxis Bad Mergentheim

    Bad Mergentheim, 97980

  • Universitaetsklinikum der Ruhr-Universitaet Bochum

    Bad Oeynhausen, 32545

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117

  • Velocity Clinical Research GmbH

    Berlin, 10787

  • Diabetespraxis Dr. Hermann Braun

    Berlin, 13187

  • Mvz am Bahnhof Spandau

    Berlin, 13597

  • Zentrum fuer Klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04910

  • InnoDiab Forschung

    Essen, 45136

  • Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin

    Falkensee, 14612

  • Diabeteszentrum Hamburg West

    Hamburg, 22607

  • Endokrinologikum Hamburg

    Hamburg, 22767

  • Diabetologische Schwerpunktpraxis Hohenmoelsen

    Hohenmölsen, 06679

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • AmBeNet GmbH

    Leipzig, 04107

  • Kardiologische Praxis Doktor Jens Taggeselle

    Markkleeberg, 04416

  • Centrum für Diagnostik und Gesundheit

    München, 80809

  • Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster

    Münster, 48145

  • Red-Institut GmbH

    Oldenburg, 23758

Other trials in Germany

Canada19 sites

  • Centricity Research Brampton

    Brampton, Ontario, L6S 0C6

  • Aggarwal and Associates Ltd

    Brampton, Ontario, L6T 0G1

  • Centricity Research Vaughan

    Concord, Ontario, L4K 4M2

  • Nova Scotia Health Authority, Queen Elizabeth ii Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Winterberry Family Medicine

    Hamilton, Ontario, L8J 0B6

  • Premier Clinical Trial Network

    Hamilton, Ontario, L8L 5G4

  • Centricity Research Quebec City

    Lévis, Quebec, G6W 0M5

  • Milestone Research

    London, Ontario, N5W 6A2

  • Institut de recherches cliniques de Montreal

    Montreal, Quebec, H2W 1R7

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • Centricity Research Ottawa LMC

    Nepean, Ontario, K2J 0V2

  • Your Research Network Inc.

    Niagara Falls, Ontario, L2H 1H5

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B 3H7

  • Centricity Research Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3

  • Bluewater Clinical Research Group Incorporated

    Sarnia, Ontario, N7T 4X3

  • tlc Diabetes and Endocrinology

    Surrey, British Columbia, V3T 2V6

  • Albion Finch Medical Centre

    Toronto, Ontario, M9V 4B4

  • Diex Recherche Trois Rivieres

    Trois-Rivières, Quebec, G9A 4P3

  • Chronic Disease Innovation Centre

    Winnipeg, Manitoba, R2V 3M3

Other trials in Canada

Poland12 sites

  • Salvia-Lekston i Madej Spolka Jawna

    Katowice, 40-772

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-338

  • Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski

    Lublin, 20-011

  • Ekamed Spolka z Ograniczona Odpowiedzialnoscia

    Lublin, 20-718

  • Medicome Spolka z Ograniczona Odpowiedzialnoscia

    Oświęcim, 32-600

  • Velocity Nova Sp zoo Velocity Pulawy

    Puławy, 24-100

  • NZOZ Przychodnia Specjalistyczna A Wittek H Rudzki spolka jawna

    Ruda Śląska, 41-709

  • Velocity Nova Sp zoo Velocity Staszow

    Staszów, 28-200

  • Tomasz Blicharski Lubelskie Centrum Diagnostyczne

    Świdnik, 21-040

  • Nbr Polska Tomasz Klodawski

    Warsaw, 00-710

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

    Warsaw, 02-507

  • Wromedica I Bielicka A Strzalkowska SC

    Wroclaw, 51-685

Other trials in Poland

South Korea12 sites

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355

  • Yeungnam University Medical Center

    Daegu, 42415

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • KyungHee University Gangdong Hospital

    Seoul, 05278

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon-do, 26426

Other trials in South Korea

Czechia11 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • CCR Ostrava sro

    Ostrava, 702 00

  • Diahelp sro

    Pardubice, 530 02

  • Pratia Pardubice as

    Pardubice, 530 02

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Institut klinicke a experimentalni mediciny

    Prague, 140 21

  • Milan Kvapil sro

    Prague, 149 00

  • Restrial sro

    Prague, 181 00

  • Endokrinologie Cerny Most sro

    Prague, 198 00

  • Milan Kvapil sro

    Pribram VIII, 261 01

Other trials in Czechia

Hungary11 sites

  • Lausmed Kft

    Baja, 6500

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

  • Clinexpert Kft

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • ClinDiab Kft

    Budapest, 1089

  • MED-TIMA Kft

    Budapest, 1132

  • Borvo Clinic Kft

    Debrecen, 4025

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Komaromi Selye Janos Korhaz

    Komárom, 2900

  • Borbanya Praxis Egeszsegugyi Kft

    Nyíregyháza, 4405

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

Other trials in Hungary

Japan11 sites

  • Mazda Hospital of Mazda Motor Corporation

    Aki-gun, Hiroshima, 735-8585

  • Shiraiwa Medical Clinic

    Kashiwara-shi, Osaka, 582-0005

  • Morizono Medical Clinic

    Kitakyusyu-shi, Fukuoka, 807-0072

  • Morinaga Ueno Clinic

    Kumamoto, Kumamoto, 860-0863

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, Ehime, 790-0034

  • Yutenji Medical Clinic

    Meguro-ku, Tokyo, 153-0053

  • Medical Corporation Ouitsukai Kanno Naika

    Mitaka-shi, Tokyo, 181-0013

  • Nakamoto Medical Clinic

    Mito, Ibaraki, 310-0826

  • Nakakinen Clinic

    Naka, Ibaraki, 311-0113

  • Suruga Clinic

    Shizuoka, Shizuoka, 424-0855

  • Ohishi Naika Clinic

    Tsuchiura-shi, Ibaraki, 300-0835

Other trials in Japan

United Kingdom11 sites

  • Ormeau Clinical Trials Ltd

    Belfast, BT28BG

  • FutureMeds Birmingham

    Birmingham, B21 9RY

  • Layton Medical Centre

    Blackpool, FY3 7EN

  • Waterloo Medical Centre

    Blackpool, FY4 3AD

  • Southmead Hospital

    Bristol, BS10 5NB

  • Staploe Medical Centre

    Ely, CB7 5JD

  • FutureMeds Glasgow

    Glasgow, G20 7BE

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre

    Leicester, LE5 4PW

  • Aintree University Hospital

    Liverpool, L9 7AL

  • Clifton Medical Centre

    Rotherham, S65 1DA

Other trials in United Kingdom

Argentina7 sites

  • Centro Medico Viamonte

    CABA, Buenos Aires, 1120

  • Cedic Centro de Investigacion Clinica

    CABA, Buenos Aires, C1060ABN

  • Cemedic Centro de Especialidades Medicas

    CABA, Buenos Aires, C1407GTN

  • Maffei Centro Medico

    CABA, Buenos Aires, C1425AGC

  • Consultorios Medicos Dr Besada

    CABA, Buenos Aires, C1426ABP

  • Cinme - Centro de Investigaciones Metabolicas

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1056ABI

  • Ciprec Centro de Investigacion y Prevencion Cardiovascular

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAT

Other trials in Argentina

Italy7 sites

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138

  • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

    Chieti, 66100

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Centro Cardiologico Monzino

    Milan, 20138

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

    Milan, 20157

  • Ospedale Civico, Di Cristina e Benfratelli

    Palermo, 90127

Other trials in Italy

Bulgaria6 sites

  • Ambulatory for specialized outpatient medical aid in endocrinology-Dr Albena Dinkova EOOD

    Pleven, 5801

  • Diagnostic - Consultative Center XX - Sofia EOOD

    Sofia, 1404

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, 1407

  • University Multiprofile Hospital for Active Treatment Sofiamed OOD

    Sofia, 1750

  • Prevencia-2000-Medical center for outpatient medical aid OOD

    Stara Zagora, 6000

  • Medical Center Berbatov EOOD

    Yambol, 8600

Other trials in Bulgaria

Puerto Rico1 site

  • Latin Clinical Trial Center

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Being tested
Maridebart cafraglutide, Placebo
Keywords
Type 2 Diabetes Mellitus, T2DM, Obesity, Overweight, Maridebart Cafraglutide, AMG 133, MariTide, Chronic Weight Management
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Overweight

What participants receive

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

  • Maridebart cafraglutideDrug

    Also called AMG 133, MariTide

    Maridebart cafraglutide will be adminstered SC.

  • PlaceboDrug

    Placebo will be adminstered SC.

Study groups in NCT06858878
Study groupRoleWhat they receive
Maridebart Cafraglutide High DoseExperimentalParticipants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Receives: Drug: Maridebart cafraglutide
Maridebart Cafraglutide Medium DoseExperimentalParticipants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Receives: Drug: Maridebart cafraglutide
Maridebart Cafraglutide Low DoseExperimentalParticipants will receive maridebart cafraglutide low dose SC for 72 weeks.
Receives: Drug: Maridebart cafraglutide
PlaceboPlacebo comparatorParticipants will receive placebo SC for 72 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Percent Change from Baseline in Body Weight at Week 72

    Measured: Baseline and Week 72

Secondary outcomes (28)

  1. Change from Baseline in Waist Circumference at Week 72

    Measured: Baseline and Week 72

  2. Participant achieving ≥ 5% reduction in body weight from baseline at week 72

    Measured: Baseline and Week 72

  3. Participant achieving ≥ 10% reduction in body weight from baseline at week 72

    Measured: Baseline and Week 72

  4. Participant achieving ≥ 15% reduction in body weight from baseline at week 72

    Measured: Baseline and Week 72

  5. Change from Baseline in Systolic Blood Pressure (SBP) at Week 72

    Measured: Baseline and Week 72

  6. Percent Change from Baseline in Fasting Triglycerides at Week 72

    Measured: Baseline and Week 72

  7. Change from Baseline in Fasting Plasma Glucose at Week 72

    Measured: Baseline and Week 72

  8. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

    Measured: Baseline and Week 72

  9. Participant achieving HbA1c < 7% at week 72

    Measured: Week 72

  10. Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72

    Measured: Baseline and Week 72

  11. Change from Baseline in Body Weight at Week 72

    Measured: Baseline and Week 72

  12. Participant achieving ≥ 20% reduction in body weight from baseline at week 72

    Measured: Baseline and Week 72

  13. Change from Baseline in Body Mass Index (BMI) at Week 72

    Measured: Baseline and Week 72

  14. Participant achieving HbA1c ≤ 6.5% at week 72

    Measured: Week 72

  15. Participant achieving HbA1c < 5.7%, at week 72

    Measured: Week 72

  16. Percent Change from Baseline in Fasting Insulin at Week 72

    Measured: Baseline and Week 72

  17. Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72

    Measured: Baseline and Week 72

  18. Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72

    Measured: Baseline and Week 72

  19. Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol

    Measured: Baseline and Week 72

  20. Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)

    Measured: Baseline and Week 72

  21. Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)

    Measured: Baseline and Week 72

  22. Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)

    Measured: Baseline and Week 72

  23. Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C)

    Measured: Baseline and Week 72

  24. Change from Baseline in Diastolic Blood Pressure DBP at Week 72

    Measured: Baseline and Week 72

  25. Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72

    Measured: Baseline and Week 72

  26. Number of Participants who Experienced Treatment-emergent Adverse Events

    Measured: Up to Week 84

  27. Number of Participants who Experienced Serious Adverse Events

    Measured: Up to Week 84

  28. Plasma Concentration of Maridebart Cafraglutide at Week 72

    Measured: Week 72

Timeline

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

  1. First posted5 Mar 2025
  2. Study start17 Mar 2025
  3. Primary completion21 Jan 2027 (estimated)
  4. Study completion16 Apr 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858878
Sponsor's protocol ID
20210184
Acronym
MARITIME-2
Status last verified
Dec 2025
First submitted
28 Feb 2025
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maridebart cafraglutide in people with Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, run by Amgen at 187 sites in 13 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 8 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States, Germany, Canada, Poland, South Korea and 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 in Body Weight at Week 72 (time frame: Baseline and Week 72). 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 NCT06858878.

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 31 Dec 2025.

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