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

January 14, 2026 updated by: Amgen

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
592

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2006
        • Royal Prince Alfred Hospital (RPAH) Clinic
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Clinical Medical and Analytical eXellence CMAX
    • Victoria
      • Clayton, Victoria, Australia, 3146
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne
      • Heidelberg Heights, Victoria, Australia, 3081
        • Austin Health, Heidelberg Repatriation Hospital
      • Melbourne, Victoria, Australia, 3004
        • Baker Heart and Diabetes Institute
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • University Of Calgary
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Centricity Research Brampton Endocrinology
      • Concord, Ontario, Canada, L4K 4M2
        • Centricity Research Vaughan Endocrinology
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Institut universitaire de cardiologie et de pneumologie de Québec
      • Québec, Quebec, Canada, G1V 4W2
        • Clinique des Maladies Lipidiques de Quebec Incorporated
  • Czechia
      • Prague, Czechia, 128 08
        • Vseobecna Fakultni nemocnice v Praze
      • Prague, Czechia, 140 21
        • Institut Klinické a Experimentální Medicíny
      • Prague, Czechia, 116 94
        • Endokrinologicky ustav
  • Germany
      • Berlin, Germany, 10117
        • Charite - Universitaetsmedizin Berlin, Campus Mitte
      • Hamburg, Germany, 22607
        • Diabeteszentrum Hamburg West
      • Leipzig, Germany, 04103
        • Universitaetsmedizin Leipzig
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Prince of Wales Hospital
  • Hungary
      • Budapest, Hungary, 1021
        • Budapesti Szent Ferenc Korhaz
      • Budapest, Hungary, 1033
        • Clinexpert Kft
      • Encs, Hungary, 3860
        • CRU Hungary Kft
      • Pécs, Hungary, 7624
        • Pécsi Tudományegyetem Klinikai Központ
  • Japan
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0034
        • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 810-0001
        • Wellness Tenjin Clinic
    • Gifu
      • Hashima-gun, Gifu, Japan, 501-6061
        • Matsunami Health Promotion Clinic
    • Hiroshima
      • Aki-gun, Hiroshima, Japan, 735-8585
        • Mazda Hospital of Mazda Motor Corporation
    • Ibaraki
      • Naka, Ibaraki, Japan, 311-0113
        • Nakakinen clinic
      • Naka, Ibaraki, Japan, 311-0133
        • Nishiyamado Keiwa Hospital
    • Osaka
      • Kashiwara-shi, Osaka, Japan, 582-0005
        • Shiraiwa Medical Clinic
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 103-0025
        • Nihonbashi Sakura Clinic
      • Shibuya-ku, Tokyo, Japan, 151-0051
        • Mih Clinic Yoyogi
  • Poland
      • Bydgoszcz, Poland, 85-752
        • AthleticoMed
      • Gdansk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House Spzoo
      • Lodz, Poland, 90-338
        • Centrum Terapii Wspolczesnej
      • Lodz, Poland, 90-349
        • AppleTreeClinics Network Spzoo
      • Lublin, Poland, 20-078
        • Clinical Best Solutions Sp zoo Spolka komandytowa
      • Wroclaw, Poland, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • South Korea
      • Goyang-si, Gyeonggi-do, South Korea, 10326
        • Dongguk University Ilsan Hospital
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital
  • Spain
    • Andalusia
      • Castilleja de la Cuesta, Andalusia, Spain, 41950
        • Hospital Vithas Sevilla
      • Málaga, Andalusia, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
    • Catalonia
      • Lleida, Catalonia, Spain, 25198
        • Hospital Universitario Arnau de Vilanova Lleida
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Complexo Hospitalario Universitario A Coruña
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Alliance for Multispecialty Research Mobile
    • Arizona
      • Phoenix, Arizona, United States, 85044
        • Foothills Research Center
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth
    • California
      • Long Beach, California, United States, 90815
        • Ark Clinical Research- Long Beach
      • Tustin, California, United States, 92780
        • Orange County Research Center
      • Tustin, California, United States, 92780
        • Ark Clinical Research- Tustin
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Alliance for Multispecialty Research Miami
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
    • Kansas
      • Newton, Kansas, United States, 67114
        • Alliance for Multispecialty Research Newton
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Louisville Metabolic and Atherosclerosis Research Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research - Marrero
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
      • Kansas City, Missouri, United States, 64114
        • Alliance for Multispecialty Research Kansas City
    • New York
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Research Innovations LLC dba Internal Medicine Care Inc
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance for Multispecialty Research Norman
    • Tennessee
      • Elizabethton, Tennessee, United States, 37643
        • Medical Care LLC
    • Texas
      • Brownsville, Texas, United States, 78520
        • PanAmerican Clinical Research LLC
      • Brownsville, Texas, United States, 78526
        • Headlands Research Brownsville
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Clinic
      • San Antonio, Texas, United States, 78284
        • Texas Diabetes Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A: Maridebart Cafraglutide
Part 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.
Drug: Placebo
Participants will receive placebo by SC injection.
Biological: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Other Names:
  • AMG 133
Placebo Comparator: Cohort A: Placebo
Part 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.
Drug: Placebo
Participants will receive placebo by SC injection.
Biological: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Other Names:
  • AMG 133
Experimental: Cohort B: Maridebart Cafraglutide
Part 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.
Drug: Placebo
Participants will receive placebo by SC injection.
Biological: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Other Names:
  • AMG 133
Placebo Comparator: Cohort B: Placebo
Part 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.
Drug: Placebo
Participants will receive placebo by SC injection.
Biological: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Other Names:
  • AMG 133

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change From Baseline to Week 52 in Body Weight
Time Frame: Baseline and Week 52
Baseline and Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Fasting Serum Insulin
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Fasting Plasma Glucose
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Waist Circumference
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Body Weight
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Lean Body Mass Using DEXA
Time Frame: Baseline and Week 52
Analyzed in a subset of participants.
Baseline and Week 52
Change from Baseline to Week 52 in Body Mass Index (BMI)
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Total Cholesterol
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in non-HDL-C
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Triglycerides
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Free Fatty Acids (FFA)
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)
Time Frame: Baseline and Week 52
Baseline and Week 52
Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA)
Time Frame: Baseline and Week 52
Analyzed in a subset of participants.
Baseline and Week 52
Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide
Time Frame: Up to Week 64
Up to Week 64
Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide
Time Frame: Up to Week 64
Up to Week 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20190218
  • 2023-510470-13-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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