NCT07684235ClinicalTrials.gov

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight

RecruitingTaking participants now, according to the registry record.

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In brief

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Phase 33,200 participants sought87 sites4 countries

Registered in 1 registry

ClinicalTrials.govNCT07684235Open this record at ClinicalTrials.govSynced 2 weeks ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2026-07-06; recorded start 2026-07-23
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 303 other studies in this databaseCounted from the lead sponsor named in the record (Amgen)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding13/20
Double-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 31 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 3,200 participants (target), run at 87 sites, across 4 countries.

How this score is built

Enrolment34/40
3,200 participants (target)
Site count18/25
31 sites
Country count7/15
2 countries
Planned duration6/10
Planned over about 20 months
Sponsor scale9/10
Amgen has led 301 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Conditions

Obesity
Overweight

Eligibility

Eligibility
Sex	All
Ages	18 Years – 99 Years
Healthy volunteers	No

Eligibility as written in the registry

Inclusion Criteria: * Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Completed the parent trial (2010181) * Completed week 72 visit in parent trial * Did not permanently discontinue trial intervention in parent trial * Randomized within 7 Days of week 72 visit in the parent trial * Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention Exclusion Criteria: * Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity * Body mass index ≤ 18.5 kilograms per meter square (kg/m\^2) * Participant has known sensitivity to any of the products or components to be administered during dosing * History of ischemic optic neuropathy * Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ. * Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer. * Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization * Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization. * Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator. * History or evidence of any other clinically significant disorder, condition, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety. * Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or * Planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention. * Major surgical procedures planned during the trial. * Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator. * Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	DOUBLE (2)
Enrolment	3,200 participants sought

Sponsor and collaborators

Amgen Sponsor

Arms and interventions

Maridebart Cafraglutide Low Dose Q4WEXPERIMENTAL
Participants who received low dose of maridebart cafraglutide in the parent trial (20210181 \[NCT06858839\]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks(Q4W).
Maridebart Cafraglutide Medium Dose Q4WEXPERIMENTAL
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.
Maridebart Cafraglutide Medium Dose Q8WEXPERIMENTAL
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8weeks (Q8W).
Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)PLACEBO_COMPARATOR
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Maridebart Cafraglutide High Dose Q4WEXPERIMENTAL
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.
Maridebart Cafraglutide High Dose Q8WEXPERIMENTAL
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.
Maridebart Cafraglutide High Dose Q12WEXPERIMENTAL
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC once in 12 weeks (Q12W).
Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)PLACEBO_COMPARATOR
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)EXPERIMENTAL
Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.
Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)EXPERIMENTAL
Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.

Interventions

Drug Maridebart cafraglutide
Administered subcutaneously
Drug Placebo
Administered subcutaneously.

Outcome measures

Primary outcome
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Time frame Baseline of parent trial (20210181) to Week 48 of current trial
Primary outcome
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame Baseline of current trial up to 60 weeks
Secondary outcome
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Time frame Baseline of parent trial to Week 48 of current trial
Secondary outcome
Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline of the Parent Trial
Time frame Baseline of parent trial to Week 48 of current trial
Secondary outcome
Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline of the Parent Trial
Time frame Baseline of parent trial to Week 48 of current trial
Secondary outcome
Percentage of Participants Achieving ≥20% Reduction in Body Weight from Baseline of the Parent Trial
Time frame Baseline of parent trial to Week 48 of current trial
Secondary outcome
Change from Baseline of the Parent Trial in Waist Circumference
Time frame Baseline of parent trial to Week 48 of current trial
Secondary outcome
Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time frame Baseline of parent trial to Week 48 of current trial
Secondary outcome
Percent Change from Baseline in Body Weight
Time frame Baseline of current trial to Week 48
Secondary outcome
Percentage of Participants with No Body Weight Gain of >3% From Baseline
Time frame Week 48 of current trial
Secondary outcome
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Time frame Week 48 of current trial
Secondary outcome
Percentage of Body Weight Reduction Maintained from the Parent Trial
Time frame Baseline of parent trial to Week 48 of current trial
Secondary outcome
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial
Time frame Baseline of parent trial to Week 48 of current trial

Dates

Dates
Start date	July 23, 2026 (actual)
Primary completion	December 26, 2027 (estimated)
Completion	March 19, 2028 (estimated)
First posted	July 6, 2026 (actual)
Last updated	September 3, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

87 sites are recruiting

Australia

Australia
Facility	City	State or region	Status
Emeritus Research Sydney	Botany	New South Wales	Recruiting
Emeritus Research Camberwell	Camberwell	Victoria	Recruiting
Novatrials	Charlestown	New South Wales	Recruiting
Canopy Clinical Sutherland	Miranda	New South Wales	Recruiting
Canopy Clinical Altona North	North Altona	Victoria	Recruiting
Fusion Clinical Research	Norwood	South Australia	Recruiting
Canopy Clinical Wollongong	Wollongong	New South Wales	Recruiting

Japan

Japan
Facility	City	State or region	Status
Doujin Memorial Foundation, Meiwa Hospital	Chiyoda-ku	Tokyo	Recruiting
Tokyo Asbo Clinic	Chuo-ku	Tokyo	Recruiting
Medical Corp Seikoukai New Medical Research System Clinic	Hachioji-shi	Tokyo	Recruiting
Medical Corporation AOT Shinagawa Strings Clinic	Minato-ku	Tokyo	Recruiting
Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo	Recruiting
Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic	Suginami-ku	Tokyo	Recruiting
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic	Yokohama	Kanagawa	Recruiting

Puerto Rico

Puerto Rico
Facility	City	Status
Ponce Medical School Foundation Inc	Ponce	Recruiting
Puerto Rico Medical Research Inc.	Ponce	Recruiting
Latin Clinical Trial Center	San Juan	Recruiting

United States

United States
Facility	City	State or region	Status
Pinnacle Research Group LLC	Anniston	Alabama	Recruiting
Washington Center for Weight Management and Research, Inc	Arlington	Virginia	Recruiting
Elligo Clinical Research Center	Austin	Texas	Recruiting
Velocity Clinical Research - Baton Rouge	Baton Rouge	Louisiana	Recruiting
Johnson County Clinical Trials Juno Bellaire	Bellaire	Texas	Recruiting
Velocity Clinical Research- Binghamton	Binghamton	New York	Recruiting
Pantheon Clinical Research	Bountiful	Utah	Recruiting
Flourish Research - Great Lakes Clinical Trials	Chicago	Illinois	Recruiting
Velocity Clinical Research - Cincinnati	Cincinnati	Ohio	Recruiting
Clinical Trial Investigator Clinical Research Center	Cincinnati	Ohio	Recruiting
Cedar Health Research, LLC	Dallas	Texas	Recruiting
Alliance For Multispecialty Research - Daphne	Daphne	Alabama	Recruiting
Epic Medical Research - Red Oak	DeSoto	Texas	Recruiting
Velocity Clinical Research - Providence	East Greenwich	Rhode Island	Recruiting
Great Lakes Research Institute El Paso Research	El Paso	Texas	Recruiting
Cedar Health Research, LLC	Euless	Texas	Recruiting
Prime Health and Wellness Sky Clinical Research Network Group	Fayette	Mississippi	Recruiting
Ark Clinical Research- Tustin	Fountain Valley	California	Recruiting
Center for Advanced Research and Education	Gainesville	Georgia	Recruiting
Tribe Clinical Research LLC Dba Mountain View Clinical Research	Greenville	South Carolina	Recruiting
Accellacare of Hickory	Hickory	North Carolina	Recruiting
East-West Medical Research	Honolulu	Hawaii	Recruiting
JCCT- Juno Northwest Houston	Houston	Texas	Recruiting
Biopharma Informatic, LLC	Houston	Texas	Recruiting
Clinical Neuroscience Solutions - Jacksonville	Jacksonville	Florida	Recruiting
Jacksonville Center for Clinical Research	Jacksonville	Florida	Recruiting
Alliance for Multispecialty Research - Kansas City	Kansas City	Missouri	Recruiting
New Phase Research and Development	Knoxville	Tennessee	Recruiting
Vector Clinical Trials	Las Vegas	Nevada	Recruiting
Palm Research Center Inc	Las Vegas	Nevada	Recruiting
Alliance for Multispecialty Research Layton Research Center	Layton	Utah	Recruiting
Ark Clinical Research- Long Beach	Long Beach	California	Recruiting
Long Beach Clinical Trials Services Inc	Long Beach	California	Recruiting

37 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 3, 2026
Site added
4 sites added (87 total)
8387
August 27, 2026
Site added
52 sites added (83 total)
3183
August 4, 2026
Status changed
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
August 4, 2026
Recruitment opened
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
August 4, 2026
Site added
31 sites added (31 total)
031

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07684235

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Australia

Japan

Puerto Rico

United States

Study documents

Changes over time