Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Subjects With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- 2024-513539-25-00
- Lead Sponsor
- Amgen Inc.
- Brief Summary
To assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 169
Subject has provided informed consent before initiation of any study-specific activities/procedures.
Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years).
BMI of ≥ 23 to ≤ 50 kg/m2 at screening
Diagnosis of T2DM at least 180 days before screening based on the World Health Organization (WHO) classification
HbA1c at screening of ≥ 7.0% (53.0 mmol/mol) and ≤ 10.5% (91.3 mmol/mol).
Treatment of T2DM with a stable dose of metformin (either immediate release or extended release, ≥ 1000 mg/day and not more than the locally approved dose) with or without an SGLT2-inhibitor for at least 90 days before screening.
Subject is able and willing to comply with the requirements of the study protocol including SMBG and completion of subject diary
Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes, except T2DM.
Fasting glucose > 270 mg/dL (15.0 mmol/L) at screening.
History of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment (based on a fundoscopic examination performed by an ophthalmologist or another suitably qualified healthcare provider [eg, optometrist] within 90 days before screening or in the period between screening and randomization).
Change in body weight > 5 kg within 90 days before screening, per subject report or medical records.
One or more episode of severe hypoglycemia within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to week 24 in hemoglobin A1c (HbA1c) Change from baseline to week 24 in hemoglobin A1c (HbA1c)
- Secondary Outcome Measures
Name Time Method Percent change from baseline to week 24 in body weight Percent change from baseline to week 24 in body weight
Achieving HbA1c < 7.0% at week 24 Achieving HbA1c ≤ 6.5% at week 24 Achieving HbA1c < 7.0% at week 24 Achieving HbA1c ≤ 6.5% at week 24
Incidence of anti-maridebart cafraglutide antibody formation including neutralizing antibodies against native glucagon-like peptide 1 (GLP-1) Incidence of anti-maridebart cafraglutide antibody formation including neutralizing antibodies against native glucagon-like peptide 1 (GLP-1)
Change from baseline to week 24 in high-sensitivity C-reactive protein (hs-CRP) Change from baseline to week 24 in high-sensitivity C-reactive protein (hs-CRP)
Achieving ≥ 5% reduction in body weight from baseline at week 24 Achieving ≥ 10% reduction in body weight from baseline at week 24 Achieving ≥ 5% reduction in body weight from baseline at week 24 Achieving ≥ 10% reduction in body weight from baseline at week 24
Change from baseline to week 24 in fasting glucose Change from baseline to week 24 in fasting glucose
Percent changes from baseline to week 24 in total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoproteincholesterol (HDL-C), non-high density lipoprotein cholesterol (non-HDL-C), very-low-density lipoprotein cholesterol (VLDL-C), triglycerides, and free fatty acids (FFA) Percent changes from baseline to week 24 in total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoproteincholesterol (HDL-C), non-high density lipoprotein cholesterol (non-HDL-C), very-low-density lipoprotein cholesterol (VLDL-C), triglycerides, and free fatty acids (FFA)
Changes from baseline to week 24 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) Changes from baseline to week 24 in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Plasma maridebart cafraglutide concentrations including observed predose plasma concentration (Cpredose) at week 20 and, if available, maximum observed plasma concentration (Cmax) as defined by week 20 day 5 to 14 postdose sample Plasma maridebart cafraglutide concentrations including observed predose plasma concentration (Cpredose) at week 20 and, if available, maximum observed plasma concentration (Cmax) as defined by week 20 day 5 to 14 postdose sample
Incidence of treatment-emergent adverse events and serious adverse events Incidence of treatment-emergent adverse events and serious adverse events
Trial Locations
- Locations (48)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy
Universita' Degli Studi G. D'Annunzio Di Chieti
🇮🇹Chieti Scalo, Italy
University Of Bari Aldo Moro
🇮🇹Bari, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
Ospedale San Raffaele S.r.l.
🇮🇹Milan, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
🇮🇹Bologna, Italy
Ospedale Isola Tiberina Gemelli Isola
🇮🇹Rome, Italy
ASST Fatebenefratelli Sacco
🇮🇹Milan, Italy
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
🇷🇴Bucharest, Romania
Consultmed S.R.L.
🇷🇴Jassi, Romania
Scroll for more (38 remaining)Fondazione Policlinico Universitario Agostino Gemelli IRCCS🇮🇹Rome, ItalyDario PitoccoSite contact+393394943559dario.pitocco@policlinicogemelli.it