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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05669599




Registration number
NCT05669599
Ethics application status
Date submitted
20/12/2022
Date registered
3/01/2023

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
20190218
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Overweight 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Maridebart Cafraglutide
Treatment: Drugs - Placebo

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.

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.

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.

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.


Treatment: Other: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.

Treatment: Drugs: Placebo
Participants will receive placebo by SC injection.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline to Week 52 in Body Weight
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving = 5% Reduction in Body Weight From Baseline at Week 52
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving = 10% Reduction in Body Weight From Baseline at Week 52
Timepoint [2] 0 0
Baseline and Week 52
Secondary outcome [3] 0 0
Achievement of = 15% Reduction in Body Weight From Baseline at Week 52
Timepoint [3] 0 0
Baseline and Week 52
Secondary outcome [4] 0 0
Achievement of = 20% Reduction in Body Weight From Baseline at Week 52
Timepoint [4] 0 0
Baseline and Week 52
Secondary outcome [5] 0 0
Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)
Timepoint [5] 0 0
Baseline and Week 52
Secondary outcome [6] 0 0
Change from Baseline to Week 52 in Fasting Serum Insulin
Timepoint [6] 0 0
Baseline and Week 52
Secondary outcome [7] 0 0
Change from Baseline to Week 52 in Fasting Plasma Glucose
Timepoint [7] 0 0
Baseline and Week 52
Secondary outcome [8] 0 0
Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)
Timepoint [8] 0 0
Baseline and Week 52
Secondary outcome [9] 0 0
Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)
Timepoint [9] 0 0
Baseline and Week 52
Secondary outcome [10] 0 0
Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide
Timepoint [10] 0 0
Up to Week 64
Secondary outcome [11] 0 0
Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide
Timepoint [11] 0 0
Up to Week 64
Secondary outcome [12] 0 0
Change from Baseline to Week 52 in Waist Circumference
Timepoint [12] 0 0
Baseline and Week 52
Secondary outcome [13] 0 0
Change from Baseline to Week 52 in Body Weight
Timepoint [13] 0 0
Baseline and Week 52
Secondary outcome [14] 0 0
Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)
Timepoint [14] 0 0
Baseline and Week 52
Secondary outcome [15] 0 0
Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)
Timepoint [15] 0 0
Baseline and Week 52
Secondary outcome [16] 0 0
Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA)
Timepoint [16] 0 0
Baseline and Week 52
Secondary outcome [17] 0 0
Change from Baseline to Week 52 in Lean Body Mass Using DEXA
Timepoint [17] 0 0
Baseline and Week 52
Secondary outcome [18] 0 0
Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)
Timepoint [18] 0 0
Baseline and Week 52
Secondary outcome [19] 0 0
Change from Baseline to Week 52 in Body Mass Index (BMI)
Timepoint [19] 0 0
Baseline and Week 52
Secondary outcome [20] 0 0
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Timepoint [20] 0 0
Baseline and Week 52
Secondary outcome [21] 0 0
Percent Change From Baseline in Total Cholesterol
Timepoint [21] 0 0
Baseline and Week 52
Secondary outcome [22] 0 0
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Timepoint [22] 0 0
Baseline and Week 52
Secondary outcome [23] 0 0
Percent Change From Baseline in non-HDL-C
Timepoint [23] 0 0
Baseline and Week 52
Secondary outcome [24] 0 0
Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)
Timepoint [24] 0 0
Baseline and Week 52
Secondary outcome [25] 0 0
Percent Change From Baseline in Triglycerides
Timepoint [25] 0 0
Baseline and Week 52
Secondary outcome [26] 0 0
Percent Change From Baseline in Free Fatty Acids (FFA)
Timepoint [26] 0 0
Baseline and Week 52

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/01/2026
Actual
Sample size
Target
Accrual to date
Final
592
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital (RPAH) Clinic - Camperdown
Recruitment hospital [2] 0 0
Clinical Medical and Analytical eXellence CMAX - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Austin Health, Heidelberg Repatriation Hospital - Heidelberg Heights
Recruitment hospital [6] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
2006 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3146 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha 1
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 2
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 4
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Leipzig
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Shatin, New Territories
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Encs
Country [29] 0 0
Hungary
State/province [29] 0 0
Pecs
Country [30] 0 0
Japan
State/province [30] 0 0
Ehime
Country [31] 0 0
Japan
State/province [31] 0 0
Fukuoka
Country [32] 0 0
Japan
State/province [32] 0 0
Gifu
Country [33] 0 0
Japan
State/province [33] 0 0
Hiroshima
Country [34] 0 0
Japan
State/province [34] 0 0
Ibaraki
Country [35] 0 0
Japan
State/province [35] 0 0
Osaka
Country [36] 0 0
Japan
State/province [36] 0 0
Tokyo
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Goyang-si, Gyeonggi-do
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Incheon
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seongnam-si, Gyeonggi-do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Poland
State/province [41] 0 0
Bydgoszcz
Country [42] 0 0
Poland
State/province [42] 0 0
Gdansk
Country [43] 0 0
Poland
State/province [43] 0 0
Lodz
Country [44] 0 0
Poland
State/province [44] 0 0
Lublin
Country [45] 0 0
Poland
State/province [45] 0 0
Wroclaw
Country [46] 0 0
Spain
State/province [46] 0 0
Andalucía
Country [47] 0 0
Spain
State/province [47] 0 0
Cataluña
Country [48] 0 0
Spain
State/province [48] 0 0
Galicia
Country [49] 0 0
Taiwan
State/province [49] 0 0
Kaohsiung
Country [50] 0 0
Taiwan
State/province [50] 0 0
Taichung
Country [51] 0 0
Taiwan
State/province [51] 0 0
Tainan
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05669599