maridebart cafraglutide (AMG 133) / Amgen - LARVOL DELTA

A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations (clinicaltrials.gov) - P1 | N=349 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Hepatology

20220196: Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV) (clinicaltrialsregister.eu) - P2/3 | N=5564 | Recruiting | Sponsor: Amgen Inc.

New P2/3 trial • Atherosclerosis • Cardiovascular • Genetic Disorders • Obesity

20230225: Maridebart Cafraglutide versus Placebo in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy (MARITIME-OSA-1) (clinicaltrialsregister.eu) - P2/3 | N=115 | Not yet recruiting | Sponsor: Amgen Inc.

New P2/3 trial • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Amgen

New P2 trial • Genetic Disorders • Obesity

The Effect of AMG 133 on Gastric Emptying (clinicaltrials.gov) - P1 | N=57 | Completed | Sponsor: Amgen

New P1 trial • Genetic Disorders • Obesity

A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the Body (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: Amgen

New P1 trial • Genetic Disorders • Obesity • Renal Disease

A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Amgen

New P1 trial • Hepatology

Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations (clinicaltrials.gov) - P1 | N=348 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Effect of Maridebart Cafraglutide on the Heart's Electrical Activity (clinicaltrials.gov) - P1 | N=81 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

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 (clinicaltrials.gov) - P2 | N=592 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Amgen CEO says weight loss drug can address ‘patient persistence issue’ (cnbc) - "Amgen revealed Monday that a trial of its experimental GLP-1 drug, MariTide, showed that patients were able to maintain weight loss for two years when given a monthly injection. Right now, most widely-used weight loss injections are taken weekly."

P2 data • Obesity • Type 2 Diabetes Mellitus

MARITIME-OSA-1: Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations (clinicaltrials.gov) - P1 | N=340 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations (clinicaltrials.gov) - P1 | N=340 | Not yet recruiting | Sponsor: Amgen

New P1 trial • Genetic Disorders • Obesity

A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity (clinicaltrials.gov) - P1 | N=59 | Completed | Sponsor: Amgen

New P1 trial • Genetic Disorders • Obesity

MARITIME-3-J: Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease (clinicaltrials.gov) - P3 | N=279 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2027 ➔ Jul 2027 | Trial primary completion date: Jul 2027 ➔ Apr 2027

Enrollment closed • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Once-Monthly Maridebart Cafraglutide Shows Up to 16% Weight Loss (AJMC) - "The trial (NCT05669599) included 592 adults and tested 11 dosing strategies across 2 cohorts, with a primary end point of percent change in body weight between baseline and week 52...Based on the treatment policy estimand—or the intention-to-treat—participants with obesity lost a mean of 12.3% to 16.2% of body weight at 52 weeks across the maridebart cafraglutide subgroups, compared with 2.5% weight loss with placebo. Patients with both obesity and T2D lost a mean 8.4% to 12.3% of their weight with treatment compared with 1.7% with placebo....Participants receiving the once-monthly injection lost substantially more fat mass than those receiving placebo, with reductions of about 26% to 37% in adults with obesity and about 17% to 34% in adults with obesity and T2D, compared with 9% and 4% in the placebo groups, respectively."

P2 data • Obesity • Type 2 Diabetes Mellitus

Once-Monthly Maridebart Cafraglutide in Obesity - A Phase 2 Trial. (PubMed, N Engl J Med) - No abstract available

Journal • P2 data • Genetic Disorders • Obesity

Effect of Maridebart Cafraglutide on the Heart's Electrical Activity (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A metabolic comparison of GIPR agonism versus GIPR antagonism in male mice. (PubMed, Diabetes Obes Metab) - "Our data highlights the distinct metabolic effects of GIPR agonism and antagonism, offering insights for their future application in personalised metabolic disease treatments. Further human studies are needed to understand the long-term metabolic impacts of these therapies."

Journal • Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

MARITIME-OSA-2: Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A Small Molecule Glucose Dependent Insulinotropic Peptide Receptor Antagonist for Treating Obesity (OBESITY WEEK 2025) - "It's noted that Tirzepatide, a dual GLP-1R and GIP receptor (GIPR) agonist, and Maridebart cafraglutide (as known as MariTide or AMG133), a GIPR antibody fused with peptide GLP-1RA, both demonstrated greater reduction of body weight in humans... Small molecule GIPR antagonists discovered by Eccogene provide potential therapeutic options for treating obesity and other cardiometabolic diseases."

Cardiovascular • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Effect of Maridebart Cafraglutide on the Heart's Electrical Activity (clinicaltrials.gov) - P1 | N=82 | Not yet recruiting | Sponsor: Amgen

New P1 trial • Genetic Disorders • Obesity