NNC0487-0111 Formulations for Obesity
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Novo Nordisk A/S
No Placebo Group
Trial Summary
What is the purpose of this trial?
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. Please consult with the trial investigator for guidance.
What data supports the idea that the drug NNC0487-0111 Formulations for Obesity is an effective treatment?
The available research does not provide specific data on the effectiveness of NNC0487-0111 Formulations for Obesity. Instead, it discusses other drugs like orlistat, sibutramine, and rimonabant, which have shown moderate weight reduction and improvements in health conditions related to obesity. Without specific data on NNC0487-0111, we cannot compare its effectiveness to these other treatments.12345
What safety data is available for the obesity treatment NNC0487-0111?
The provided research does not contain specific safety data for NNC0487-0111 or its other names (Amycretin, NN-9487, NN9487, NNC-04870111). The articles discuss general safety concerns and adverse events associated with anti-obesity medications, including cardiovascular and kidney complications, but do not mention NNC0487-0111 specifically. Further investigation into clinical trial data or specific studies on NNC0487-0111 would be necessary to obtain detailed safety information.678910
Is the drug NNC0487-0111 a promising treatment for obesity?
Yes, NNC0487-0111, also known as Amycretin, is a promising drug for obesity. It is an amylin analogue, which means it mimics a natural hormone that helps control appetite and food intake. This drug can help reduce food intake and lead to significant weight loss, making it a potential new option for people struggling with obesity.1011121314
Eligibility Criteria
This trial is for individuals living with overweight or obesity. Participants must be willing to undergo two phases of the study, taking different oral formulations of a weight control medicine called NNC0487-0111. Specific eligibility criteria are not provided, but typically participants should be in stable health and meet certain body weight or BMI requirements.Inclusion Criteria
I am either male or female.
Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m^2)
My health, heart function, and lab tests meet the study's requirements.
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Exclusion Criteria
Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 Nanometer (nM)) at screening
Parathyroid hormone (PTH) outside normal range at screening
Total calcium outside normal range at screening
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Treatment Details
Interventions
- NNC0487-0111 (Other)
Trial OverviewThe study tests two different tablet formulations (C and D) of NNC0487-0111, assessing how they behave in the body and their effectiveness when taken with or without food. The trial randomly assigns one of these formulations to each participant over a period of approximately 5-6 months.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Phase B: NNC0487-0111 (formulation D)Experimental Treatment1 Intervention
Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D).
Group II: Phase A: NNC0487-0111 (formulation D)Experimental Treatment1 Intervention
Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks).
Group III: Phase B: NNC0487-0111 (formulation C)Active Control1 Intervention
Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C).
Group IV: Phase A: NNC0487-0111 (formulation C)Active Control1 Intervention
Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Celerion, LincolnLincoln, NE
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Who Is Running the Clinical Trial?
Novo Nordisk A/SLead Sponsor
References
Review article: malnutrition and maltreatment--a comment on orlistat for the treatment of obesity. [2019]The prevalence of obesity has doubled in the last 10 years and is now reaching epidemic proportions. There is a significant comorbidity and financial cost associated with this disorder. Orlistat is an intestinal lipase inhibitor that is approved for the treatment of obesity. Recent randomized, double-blind, placebo-controlled trials have demonstrated the benefit of orlistat used in conjunction with a hypocaloric (low-fat) diet in facilitating weight reduction and the long-term maintenance of this weight loss. Patients treated with orlistat lost a greater amount of initial body weight compared to those who received placebo. After 24 months of treatment, weight loss of more than 5% was maintained in a greater number of those treated with orlistat. This was associated with significant reductions in cardiovascular risk factors (cholesterol, LDL cholesterol, LDL:HDL cholesterol ratio). The main adverse events are related to fat malabsorption, with potential losses of fat-soluble vitamins and other compounds. Orlistat as a treatment for obesity, when prescribed within present guidelines, can aid modest weight loss in about one-third of patients. More importantly, it can assist in the maintenance of weight loss with major medical benefits for these patients.
[Pharmacotherapy of obesity]. [2021]Diet, exercise and behavioral therapy are the basics for every treatment of obesity. If lifestyle intervention does not result in a weight loss of 5% within 3 to 6 months, an additional pharmacotherapy can be considered. Treated patients should have a BMI >/=30 kg/m(2) or at least a BMI >/=27 kg/m(2) plus accompanying comorbidities, such as type 2 diabetes, dyslipidemia or hypertension. Current guidelines list orlistat, sibutramine and rimonabant as possible options for the pharmacotherapy of obesity. These compounds result in moderate weight reduction and improvement of cardiovascular risk profile. Especially the improvement of glucose metabolism can be considered as clinically relevant. Different side effects of the various compounds need to be considered before their use. Additional options for the pharmacotherapy of obesity are currently developed, their approval, however, is unlikely to happen within the next couple of years.
Drug treatment of the overweight patient. [2018]Three medications with approval for long-term use in the treatment of obesity are currently available in the United States. Sibutramine (U.S. Food and Drug Administration [FDA] approved in 1997), orlistat (FDA approved in 1999), and rimonabant (available in Europe and given FDA approvable status in 2006 and expected to be marketed in 2007) represent modern approaches to medications used adjunctively for weight management. As demonstrated in large clinical trials of 2 to 4 years' duration, these medications significantly increase weight loss compared with placebo; weight loss with these drugs reaches a nadir between 20 and 28 weeks; weight loss, averaged 8%-10%, with the placebo contributing 4%-6% of that. Weight maintenance is demonstrated as long as adherence to medication continues. All medications have side effects that need to be considered. For sibutramine, there is a rise in blood pressure and heart rate that may require discontinuation of the drug in a small percent of patients. For orlistat, steatorrhea produces the principal gastrointestinal side effects. Rimonabant appears to have a favorable safety and tolerability profile. Nausea and gastrointestinal symptoms are the chief tolerability issue, but they are usually self-limited. In addition there are several drugs and drug combinations in phase 2 or phase 2 trials that will be reported on in the coming years.
Medical management of obesity. [2005]Obesity is the most prevalent and serious nutritional disease among western countries and is rapidly replacing undernutrition as the most common form of malnutrition in the world. Approximately 300,000 deaths a year are currently associated with overweight and obesity, second only to cigarette smoking as a leading cause of preventable death in the United States. Obesity effects 9 organ systems and is a risk factor for gastroesophageal reflux disease, nonalcoholic fatty liver disease, cholelithiasis, and colon cancer. Evidence-based guidelines on the identification, evaluation, and treatment of overweight and obesity have recently been developed by the National Institutes of Health to help practitioners effectively manage their patients. The body mass index is used to classify weight status and risk of disease. Treatment for obesity includes lifestyle management, consisting of diet therapy, physical activity, and behavioral modification, and may include pharmacotherapy or surgery based on level of risk. Currently only 2 medications, sibutramine and orlistat, are approved for long-term use. An initial weight loss of 10% of body weight achieved over 6 months is a recommended target. This article reviews the evaluation and management of the adult obese patient.
Current Long-Term Pharmacotherapies for the Management of Obesity. [2020]Obesity is a serious and growing worldwide health challenge associated with type 2 diabetes mellitus, cardiovascular disease, osteoarthritis, some cancers, sleep apnea, asthma, and nonalcoholic fatty liver. The Korean Society for the Study of Obesity recommends that pharmacotherapy should be considered when intensive lifestyle modifications fail to achieve a weight reduction in obese patients with a body mass index ≥25 kg/m2. Long-term medications for obesity have traditionally fallen into two major categories: centrally acting anorexiant medications and peripherally acting medications, such as orlistat. In this paper, we provide an overview of the anti-obesity medications currently available for the long-term and individualized treatment of obesity.
Mechanistically acting anti-obesity compositions/formulations of natural origin: a patent review (2010-2021). [2022]Current health trends indicate that the rate of incidence of obesity has risen considerably. According to the World Health Organization (WHO) report 2017, the issue of obesity has grown to an epidemic proportion, with over 4 million people dying every year. Orlistat, a potent pancreatic lipase (PL) inhibitor for long-term treatment of obesity has been recently reported to cause hepatic and renal toxicities. Hence, there is a need to develop newer, safer and efficacious therapeutics that targets obesity and its associated disorders.
Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. [2022]Background Obesity is a globally growing health problem, and its treatment has been challenging. The use of anti-obesity medications (AOMs) has been associated with severe adverse events (AEs). Several AOMs have been withdrawn from the market owing to documented AEs. Aim To describe, estimate and characterize the frequency of AEs attributable to the use of the AOMs, and investigate previously unreported potential AEs associated with AOMs. Method Using the US FDA Adverse Event Reporting System (FAERS) between January 2013 and June 2020, a retrospective, descriptive analysis was conducted to analyze all major reported AEs and outcomes including death, life-threatening, hospitalization, disability, and required intervention or congenital anomaly. The total numbers of AEs reports, cases, adverse reactions and outcomes were calculated for each medication. Results A total of 18,675 unique AEs reports associated with AOMs used for 15,143 patients. The mean age was 49.8 years [SD 1.83], while most patients were female adults (73.4%). The most frequently reported AEs were nausea and vomiting, followed by dizziness and headache, drug ineffectiveness, cardiovascular diseases, and kidney complications. There were 21,229 unique outcomes, including 1039 deaths (fatality ratio of 4.9% of all analyzed reports), 1613 (7.6%) life-threatening events, 7426 (35%) hospitalizations, and 1249 (5.9%) disability cases. Phentermine/topiramate fatal cases represent 6% of the overall medication's reported AEs. Cardiovascular AEs represented 31%, 23%, and 22% of phentermine, liraglutide, and phentermine/topiramate total AEs, respectively. Conclusion The analysis of FAERS database revealed numerous serious AEs associated with AOMs. These AEs can lead to serious cardiovascular and kidney complications. It is necessary to continue and systematically monitor safety of AOMs' to optimize patient anti-obesity therapy.
Drug treatment of obesity: current status and future prospects. [2022]Obesity is a growing epidemic and a major contributor to the global burden of disease. Obesity strains the healthcare systems and has profound economic and psychosocial consequences. Historically, pharmacotherapy for obesity has witnessed the rise and fall of several promising drug candidates that had to be eventually withdrawn due to unacceptable safety concerns. Currently four drugs are approved for chronic weight management in obese adults: orlistat, lorcaserin, phentermine/topiramate extended release and naltrexone/bupropion extended release. While lorcaserin and phentermine/topiramate were approved by US Food and Drug Administration (FDA) in 2012, after a gap of 13 years following the licensing of orlistat, naltrexone/bupropion has been recently approved in 2014. This review provides a brief overview of these current therapeutic interventions available for management of obesity along with the evidence of their safety and efficacy. Additionally, several novel monotherapies as well as combination products are undergoing evaluation in various stages of clinical development. These therapies if proven successful will strengthen the existing armamentarium of antiobesity drugs and will be critical to combat the global public health crisis of obesity and its associated co-morbidities.
Acute pancreatitis following orlistat therapy: report of two cases. [2018]Orlistat is a pancreatic lipase inhibitor licensed for the treatment of obesity. As obesity rates increase and non-prescription dispensing of orlistat increases, an awareness of its adverse effects is of crucial importance as complications arise more frequently from increased use. Orlistat induced pancreatitis has been described only once previously, but without a diagnostic increase in serum amylase.
Amylin as a Future Obesity Treatment. [2022]Obesity is defined as abnormal or excessive fat accumulation that contributes to detrimental health impacts. One-third of the population suffers from obesity, and it is important to consider obesity as a chronic disease requiring chronic treatment. Amylin is co-secreted with insulin from β pancreatic cells upon nutrient delivery to the small intestine as a satiety signal, acts upon sub-cortical homeostatic and hedonic brain regions, slows gastric emptying, and suppresses post-prandial glucagon responses to meals. Therefore, new pharmacological amylin analogues can be used as potential anti-obesity medications in individuals who are overweight or obese. In this narrative review, we analyse the efficacy, potency, and safety of amylin analogues. The synthetic amylin analogue pramlintide is an approved treatment for diabetes mellitus which promotes better glycaemic control and small but significant weight loss. AM833 (cagrilintide), an investigational novel long-acting acylated amylin analogue, acts as a non-selective amylin receptor. This calcitonin G protein-coupled receptor agonist can serve as an attractive novel treatment for obesity, resulting in reduction of food intake and significant weight loss in a dose-dependent manner.
Long-acting amylin analogues for the management of obesity. [2023]To summarize recent developments of long-acting amylin analogues for the treatment of obesity and to outline their mode of action.
Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. [2022]Orlistat, a gastrointestinal lipase inhibitor that reduces dietary fat absorption by approximately 30%, may promote weight loss and reduce cardiovascular risk factors.
Regulation of feeding and therapeutic application of bioactive peptides. [2022]Obesity and obesity-related diseases, such as diabetes mellitus and dyslipidemia, are worldwide pandemics; therefore, studies have been conducted energetically to elucidate the mechanism of obesity and develop anti-obesity drugs. Robust progress in the peptide chemistry and molecular biology has identified many peptides that regulate appetite and energy metabolism over the past dozen years. Several drugs, such as analogs or receptor agonists of anorectic peptides, have been developed. Overall, peptide-related drugs have powerful anti-obesity effects with fewer adverse effects than previous anti-obesity drugs. Liraglutide, a glucagon-like peptide-1 receptor agonist, was first used as an antidiabetic drug, and then high-dose liraglutide was used as an anti-obesity drug. Several candidates have been developed to explore their anti-obesity effects. Additionally, hybrid peptides consisting of two or more peptide sequences with strong anorectic effects have been designed. Here, we review peptides that are important for feeding regulation in terms of their mechanisms of action, interactions, and clinical application as anti-obesity drugs.
The obesity pipeline: current strategies in the development of anti-obesity drugs. [2006]This review provides a summary of currently available pharmaceutical therapies for the treatment of obesity, along with an overview of the pipeline of products currently in development, and the key mechanisms on which the major development candidates are based. In particular, the recent increase in understanding of the role of gut peptides in energy homeostasis is highlighted as a promising source of potential future obesity therapies.