MariTide trials recruiting now

Who the trial lists, as registered

Lists people 45 to 99. Conditions: Atherosclerotic Cardiovascular Disease; Overweight; Obesity.

• Age ≥ 45 years at screening.
• BMI of ≥ 27.0 kg/m\^2 at screening.
• History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:
• Prior MI (presumed atherothrombotic event due to plaque rupture/erosion).

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Maridebart Cafraglutide; Placebo

Registered summary

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

Where, as registered

140 US sites in 36 states; also Czechia (41), China (40), Germany (39), Poland (39), Brazil (37), Spain (33), Hungary (32), Japan (32), Netherlands (31), Argentina (30), United Kingdom (28), Slovakia (20), Turkey (Türkiye) (20), Australia (18), Canada (17), France (16), Romania (15), Greece (14), South Korea (14), Denmark (13), Italy (13), Belgium (12), Mexico (11), Bulgaria (10), Portugal (10), Austria (9), Taiwan (8), Chile (7), Sweden (7), Colombia (6), Finland (6), Singapore (6), Switzerland (6), Hong Kong (2), Puerto Rico (1).

Who the trial lists, as registered

Lists people 18 to 99. Conditions: Heart Failure With Preserved Ejection Fraction; Heart Failure With Mildly Reduced Ejection Fraction; Obesity.

• Age ≥ 18 years at the time of informed consent.
• BMI ≥ 30.0 kg/m\^2 at randomization.
• HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.
• Managed with HF standard of care therapies.

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Maridebart cafraglutide; Placebo

Registered summary

This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The full summary is on the listing.

Where, as registered

121 US sites in 30 states; also China (52), Czechia (39), Germany (31), Hungary (27), Poland (25), Japan (24), Argentina (23), United Kingdom (23), Canada (21), Brazil (19), Slovakia (19), Spain (19), Australia (16), France (16), Italy (16), Netherlands (16), Belgium (15), Greece (15), Bulgaria (13), Austria (12), Turkey (Türkiye) (12), Romania (11), Chile (10), Colombia (10), Portugal (8), Sweden (8), Denmark (7), Switzerland (7), Mexico (6), Taiwan (6), Finland (4), South Korea (4), Hong Kong (2).

Who the trial lists, as registered

Lists people 18 to 99. Conditions: Obesity; Overweight.

• 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

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Maridebart cafraglutide; Placebo

Registered summary

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).

Where, as registered

71 US sites in 27 states; also Australia (8), Japan (7), Canada (3), Puerto Rico (3).

Who the trial lists, as registered

Lists people 18 to 99. Conditions: Obesity or Overweight.

• Body Mass Index (BMI) ≥ 25 at screening.
• Weight loss of ≥ 10% on weekly GLP-1 RA.
• Stable body weight.
• Stable dose of GLP-1RA.

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Maridebart Cafraglutide

Registered summary

Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.

Where, as registered

52 US sites in 19 states; also Puerto Rico (1).

Who the trial lists, as registered

Lists people 18 to 99. Conditions: Obesity; Overweight; Diabetes Mellitus, Type 2.

• Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
• Participants completing Study 20210184 must meet the following criteria:
• Completed the Week 72 visit in Study 20210184.
• Did not permanently discontinue the investigational product in the parent trial (20210184).

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Maridebart Cafraglutide; Placebo

Registered summary

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

Where, as registered

31 US sites in 16 states; also Japan (11), Canada (1), Puerto Rico (1), United Kingdom (1).

Who the trial lists, as registered

Lists people 18 to 99. Conditions: Obesity; Overweight.

• Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m\^2), or BMI ≥ 27 to < 30 kg/m\^2 with one of the following:
• hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg
• dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.
• history of obstructive sleep apnea

5 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Maridebart cafraglutide; Autoinjector

Registered summary

The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Diabetes Mellitus, Type 2.

• HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
• Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily…
• Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m\^2) at screening.

The exclusion criteria are on the listing.

What it tests, as registered

Maridebart cafraglutide; Semaglutide

Registered summary

The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.

Where, as registered

No sites listed yet.

Who the trial lists, as registered

Lists people 18 to 60. Conditions: Overweight; Obesity.

• Male or female participants, of any race, between 18 and 60 years of age (inclusive).
• Females must not be pregnant or lactating.
• Body mass index of ≥ 25.0 to < 40.0 kilograms per square meter (kg/m\^2).
• Have a stable body weight within 3 months before screening.

The exclusion criteria are on the listing.

What it tests, as registered

Maridebart Cafraglutide

Registered summary

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products in participants living with overweight or obesity.

Where, as registered

No sites listed yet.