Maridebart Cafraglutide for Diabetes
Recruiting in Palo Alto (17 mi)
+93 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Amgen
Prior Safety Data
Trial Summary
What is the purpose of this trial?The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
What data supports the effectiveness of the drug Maridebart Cafraglutide for diabetes?
Research on similar drugs like liraglutide, which is a GLP-1 analog, shows that they can effectively lower blood sugar levels and help with weight loss in people with type 2 diabetes. These drugs are generally safe and have a low risk of causing low blood sugar when used alone.
12345Will I have to stop taking my current medications?
If you are taking medications other than metformin or a sodium-glucose cotransporter-2 inhibitor for diabetes, you will need to stop them at least 3 months before joining the trial. The trial allows the use of metformin and certain other diabetes medications, but not others.
Eligibility Criteria
This trial is for adults with Type 2 Diabetes who manage their condition through diet, exercise, or stable doses of metformin. They must be over 18 years old (or the legal age in their country if higher), have a BMI between 23-50 kg/m², and an HbA1c level between 7.0% to 10.5%. People on complex diabetes medication regimens are not eligible.Inclusion Criteria
I have had type 2 diabetes for at least 6 months.
I am at least 18 years old or the legal age in my country.
Exclusion Criteria
I haven't had a major heart event or surgery in the last 3 months and don't have severe heart failure.
I have Type 1 diabetes.
I have only used metformin or SGLT2 inhibitors for my diabetes in the last 3 months.
I haven't had cancer, except for certain skin, cervical, or prostate cancers, in the last 5 years.
I have unstable diabetic eye problems.
I have a history of pancreatitis.
Participant Groups
The study is testing Maridebart Cafraglutide's effectiveness at controlling blood sugar levels compared to a placebo. Participants will receive either the test drug or a placebo without knowing which one they're getting.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Maridebart CafraglutideExperimental Treatment1 Intervention
Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week main treatment period and meet specific criteria will have the option to begin an exploratory part 2 portion where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week main treatment period and meet specific criteria will have the option to begin an exploratory part 2 period where they will receive maridebart cafraglutide for an additional 24 weeks.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Accel Research Site - Birmingham Clinical Research UnitBirmingham, AL
Orange County Research CenterLake Forest, CA
San Jose Clinical TrialsSan Jose, CA
New Horizon Research CenterMiami, FL
More Trial Locations
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Who is running the clinical trial?
AmgenLead Sponsor
References
Exenatide: clinical aspects of the first incretin-mimetic for the treatment of type 2 diabetes mellitus. [2019]Exenatide is the first-in-class incretin mimetic for the treatment of type 2 diabetes.
Pharmacology, efficacy and safety of liraglutide in the management of type 2 diabetes. [2021]Liraglutide is a glucagon-like peptide-1 analog with pharmacokinetic properties suitable for once-daily administration approved by the Food and Drug Administration for the treatment of patients with type 2 diabetes. Clinical trial data from large, controlled studies demonstrate the safety and efficacy of liraglutide in terms of hemoglobin A(1c) (HbA(1c)) reduction, reductions in body weight, and the drug's low risk for hypoglycemic events when used as monotherapy. Liraglutide has been studied as monotherapy and in combination with metformin, glimepiride, and rosiglitazone for the treatment of type 2 diabetes. Additionally, comparative data with insulin glargine and exenatide therapy are available from Phase III trials. Once-daily administration may provide a therapeutic advantage for liraglutide over twice-daily exenatide, with similar improvements in HbA(1c) and body weight observed when liraglutide was compared with exenatide. The glucose-dependent mechanism of insulin release with incretin analog therapy holds potential clinical significance in the management of postprandial hyperglycemic excursions, with minimal risk of hypoglycemia when used with non-secretagogue medications. Data to date on patient-reported outcomes with liraglutide treatment are encouraging. The most common adverse events associated with liraglutide therapy are dose-dependent nausea, vomiting, and diarrhea. Diligent postmarketing surveillance to elucidate the risk of pancreatitis and medullary thyroid carcinoma in a heterogeneous population are likely warranted.
Liraglutide for the treatment of type 2 diabetes: a clinical update. [2022]This review updates the pharmacology, efficacy, safety, and tolerability of liraglutide, a glucagon-like peptide 1 (GLP-1) analog approved for the treatment of type 2 diabetes (T2DM) in January 2010. MEDLINE was searched (May 2009-January 1, 2011) for articles in English, using the terms liraglutide, NN2211, incretin mimetic, glucagon-like peptide (GLP)-1, and GLP-1 receptor agonist. Abstracts from key meetings (ADA 2009 and 2010, AACE 2010, EASD 2009, and EASD 2010) were also searched for relevant data. A GLP-1 analog with pharmacokinetic properties allowing once-daily administration via subcutaneous injection, liraglutide has shown clinical benefits when used as monotherapy or in combination. Liraglutide monotherapy has demonstrated efficacy in reducing hemoglobin A1c (A1C) and body weight, with low risk for hypoglycemic events. Liraglutide has also been studied in combination with metformin, glimepiride, and rosiglitazone for the treatment of T2DM. Extension studies within the Liraglutide Effects and Action in Diabetes clinical program have demonstrated the efficacy of liraglutide over 2 years of treatment. Overall, liraglutide has been shown to be well tolerated, with dose-dependent nausea, vomiting, and diarrhea being the most commonly reported adverse events in clinical trials. Extended dosing periods have demonstrated the durability of response of liraglutide with respect to glycemic control, lack of weight gain, and blood pressure benefits. Compared with exenatide and sitagliptin, liraglutide seems to offer greater improvements in A1C, fasting plasma glucose, and body weight. Adverse events commonly associated with liraglutide in clinical trials included nausea and hypoglycemia. Emerging data suggest that liraglutide may be a useful option for patients with T2DM.
Long-acting GLP-1RAs: An overview of efficacy, safety, and their role in type 2 diabetes management. [2021]Over recent decades, an improved understanding of the pathophysiology of type 2 diabetes mellitus (T2DM) and glucose regulation has led to innovative research and new treatment paradigms. The discovery of the gut peptide glucagon-like peptide-1 (GLP-1) and its role in glucose regulation paved the way for the class of GLP-1 receptor agonist compounds, or GLP-1RAs. The long-acting GLP-1RAs (dulaglutide, exenatide extended-release, liraglutide, semaglutide [injectable and oral]) are classified as such based on a minimum 24-hour duration of clinically relevant effects after administration. In phase 3 clinical trial programs of long-acting GLP-1RAs, A1C typically was reduced in the range of 1% to 1.5%, with reductions close to 2% in some studies. GLP-1RAs when used alone (without sulfonylureas or insulin) have a low risk of hypoglycemia because, like endogenous GLP-1, their insulinotropic effects are glucose-dependent. In addition to local actions in the gastrointestinal (GI) tract, GLP-1RAs stimulate receptors in the central nervous system to increase satiety, resulting in weight loss. All long-acting GLP-1RAs have, at minimum, been shown to be safe and not increase cardiovascular (CV) risk and most (liraglutide, semaglutide injectable, dulaglutide, albiglutide) have been shown in CV outcomes trials (CVOTs) to significantly reduce the risk of major cardiac adverse events. The class has good tolerability overall, with generally transient GI adverse events being most common. The weekly injectable agents offer scheduling convenience and may promote treatment adherence. One long-acting GLP-1RA is available as an oral daily tablet, which may be preferable for some patients and providers.
The importance of patient-reported outcomes in type 2 diabetes: insight from the PIONEER program with oral semaglutide. [2021]Patient-reported outcomes (PROs), including treatment satisfaction, patient well-being, and quality of life, are becoming increasingly important contributors to treatment decisions in clinical practice and the evaluation of health care services. PROs have been included in a number of clinical trials in patients with type 2 diabetes (T2D), including those investigating glucagon-like peptide-1 receptor agonists (GLP-1RAs). The first oral GLP-1RA, oral semaglutide, was approved in the United States in 2019. Four PROs were included in the PIONEER clinical study program that evaluated oral semaglutide in patients with T2D across the full diabetes disease spectrum. PRO findings in the PIONEER studies were generally similar for oral semaglutide and comparators, with some exceptions. Improvements in a number of the 36-item Short Form Survey domains were observed for oral semaglutide versus placebo, including general health, bodily pain, physical component summary, social functioning, and mental health. For general health and social functioning, differences significantly favored oral semaglutide versus empagliflozin, whereas role-physical and the physical component summary significantly favored empagliflozin compared with oral semaglutide. The Diabetes Treatment Satisfaction Questionnaire findings indicated that oral semaglutide improved feelings of unacceptably high blood sugars versus placebo (in PIONEER 4, 5, and 8) and sitagliptin (in PIONEER 7). Significant improvements in craving control and craving for savory were observed with oral semaglutide versus empagliflozin in the Control of Eating Questionnaire (in PIONEER 2). These data provide valuable information that can facilitate a patient-centered approach and guide decision-making in managed care to optimize each patient's treatment experience.