Efficacy and Safety of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-1)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

30 May 2025 → ongoing

Decision date (initial)

2025-05-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amgen Inc.

External identifiers

EU CT number

2024-515524-36-00

WHO UTN

U1111-1316-9591

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

To demonstrate that maridebart cafraglutide is superior to placebo for percentage change in body weight

Secondary objectives 6

1. To demonstrate that maridebart cafraglutide is superior to placebo for reduction in central adiposity
2. To demonstrate that maridebart cafraglutide is superior to placebo for reduction in body weight
3. To demonstrate that maridebart cafraglutide is superior to placebo for reduction in systolic blood pressure
4. To demonstrate that maridebart cafraglutide is superior to placebo for reduction in triglycerides
5. To demonstrate that maridebart cafraglutide is superior to placebo for improvement in glycemia
6. To demonstrate that maridebart cafraglutide is superior to placebo for improvement in functional health and well-being

Conditions and MedDRA coding

Chronic Weight Management

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003439-PIP02-23

Plan to share 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. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available on the Amgen Clinical Trials portal (http://www.amgen.com/datasharing).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant has provided informed consent before initiation of any study-specific ctivities/procedures.
2. Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
3. BMI ≥ 30 kg/m2 at screening, OR BMI ≥ 27 to < 30 kg/m2 at screening, with at least 1 of the following weight-related comorbidities: * hypertension: treated, or with SBP ≥ 130 mmHg or DBP ≥ 80 mmHg * dyslipidemia: treated, or with: LDL ≥ 160 mg/dL (4.1 mmol/L), or triglycerides ≥ 150 mg/dL (1.7 mmol/L), or HDL < 40 mg/dL (1.0 mmol/L) for males or HDL < 50 mg/dL (1.3 mmol/L) for females * obstructive sleep apnea * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Class I, II, or III heart failure) * metabolic dysfunction-associated steatotic liver disease
4. History of at least 1 unsuccessful attempt at weight loss by diet and exercise
5. In the opinion of the investigator, well-motivated and willing to follow study procedures for the duration of the study, including, but not limited to: following lifestyle advice, maintaining lifestyle log(s), and completing required study visits and questionnaires

Exclusion criteria 36

1. Obesity induced by other endocrinologic disorders, monogenetic or syndromic forms of obesity
2. Self-reported change in body weight > 5kg 90 days before screening
3. Previous or planned surgical, endoscopic, or device-based treatment for obesity
4. History of malignancy 5 years before screening
5. Type 1 or 2 diabetes mellitus or any other types of diabetes mellitus
6. History of chronic pancreatitis
7. History of acute pancreatitis 180 days before screening
8. Family or personal history of MTC or multiple endocrine neoplasia syndrome type 2
9. History of the following 60 days before screening: myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack
10. New York Heart Association Class IV heart failure
11. History of unstable major depressive disorder or other severe psychiatric disorder 2 years before screening
12. History of organ transplant or on transplant list
13. History of other conditions that the investigator, may preclude the participant from following the protocol and completing the study
14. Clinically significant gastric-emptying abnormality
15. Use 90 days before randomization of medications, supplements, or alternative remedies for weight loss
16. Use 90 days before randomization of glucose-lowering drugs for the treatment of diabetes
17. Use 90 days before randomization or require use during the trial of medications that may cause significant weight gain including, but not limited to chronic systemic glucocorticoid therapy, tricyclic antidepressants, atypical tetracyclic antidepressants, atypical antipsychotics, lithium, and all formulations of valproic acid
18. Is receiving treatment in another investigational device or drug study, or within 90 days since ending treatment on another investigational device or drug study. This does not apply to other investigational procedures or participation in observational research studies
19. Participation in a study that includes maridebart cafraglutide or AMG 598
20. Hemoglobin A1c ≥ 6.5% & fasting plasma glucose ≥ 126 mg/dL at screening. If only 1 of the above labs meets the threshold at screening, then the participant should be retested for both & excluded if any repeated test result meets the threshold
21. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 according to 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation or receiving dialysis at screening
22. Calcitonin ≥ 50 ng/L at screening
23. Thyroid-stimulating hormone < 0.4 mIU/L or TSH > 6.0 mIU/L with free thyroxine below the lower limit of normal at screening
24. Acute or chronic hepatitis, signs & symptoms of any liver disease other than MASLD, ALT > 3.0 x the upper limit of normal, or total bilirubin > 1.2 x ULN
25. Systolic blood pressure ≥ 180 mmHg and/or DBP ≥ 120 mmHg at screening
26. Patient Health Questionnaire-9 score of ≥ 15 on day 1 before randomization
27. Suicidal ideation of category 4 or 5 on the Columbia-Suicide Severity Rating Scale Baseline version at screening, or on the C-SSRS Since Last Visit version on day 1 before randomization
28. History of suicide attempt evaluated through C-SSRS Baseline version at screening or any suicidal behavior on the C-SSRS Since Last Visit version on day 1 before randomization
29. Participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment & the 16 weeks after last dose of investigational product
30. Participants who are breastfeeding or plan to breastfeed while on study through 16 weeks after last dose of investigational product
31. Participants planning to become pregnant while on study and 16 weeks after the last dose of investigational product
32. Participants of childbearing age with a positive pregnancy test assessed at screening and/or day 1 before randomization
33. Any disorder, unwillingness, or inability, not covered by the other exclusion criteria, that in the investigator’s opinion, might jeopardize the participant’s safety or compliance with the protocol
34. Major surgery planned during the study
35. Investigative site personnel directly affiliated with the study and/or their immediate family
36. Participant has known sensitivity to any of the products or components to be administered during dosing

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from baseline in body weight at week 72

Secondary endpoints 9

1. Change from baseline in waist circumference (cm) at week 72
2. Achieving ≥5% reduction in body weight from baseline at week 72
3. Achieving ≥10% reduction in body weight from baseline at week 72
4. Achieving ≥15% reduction in body weight from baseline at week 72
5. Achieving ≥20% reduction in body weight from baseline at week 72
6. Change from baseline in SBP (mmHg) at week 72
7. Percent change from baseline in fasting triglycerides at week 72
8. 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
9. Change from baseline in fasting plasma glucose at week 72

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1730

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 7

Locations

8 EU/EEA countries · 88 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 133 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications