Therapies for obesity, diabetes and related indications
Inventors
Spana, Carl • Dodd, John H. • Makhlina, Marie
Assignees
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Publication Number
US-10660939-B2
Publication Date
2020-05-26
Expiration Date
Abstract
The invention relates to methods, uses, compositions and formulations including a melanocortin receptor-4 agonist and a glucagon-like peptide-1 receptor agonist for treatment of obesity, diabetes, metabolic syndrome and related indications, diseases or disorders.
Core Innovation
The invention relates to treating obesity by administering to a patient a melanocortin receptor-4 agonist and a glucagon-like peptide-1 receptor agonist together. The melanocortin receptor-4 agonist is administered in a quantity sufficient to induce at least minimal weight loss when administered as a monotherapy not in conjunction with a glucagon-like peptide-1 receptor agonist, while the glucagon-like peptide-1 receptor agonist is administered in a quantity sufficient to induce glycemic control but not weight loss when administered as a monotherapy not in conjunction with a melanocortin receptor-4 agonist.
The combined method elicits a synergistic effect on treatment of obesity, and the described framework is also applied to treatment of glycemic control as a synergistic effect. The synergy is linked to the distinct monotherapy profiles of the two agents: minimal weight loss from the melanocortin receptor-4 agonist and glycemic control without weight loss from the glucagon-like peptide-1 receptor agonist.
The document also describes pharmaceutically acceptable salt and solvate/hydrate forms of MC4r agonist peptides and GLP-1 receptor agonist peptides, together with formulation components for delivering such peptides. Formulation content includes buffered isotonic aqueous carriers, excipients, preservatives, and routes including injection and nasal administration, with long-acting and controlled or sustained-release delivery approaches.
Claims Coverage
Two independent claims are identified. Each claim centers on co-administering a melanocortin receptor-4 agonist with a glucagon-like peptide-1 receptor agonist using monotherapy quantities that separately produce distinct effects, where the combination elicits a synergistic effect on obesity or glycemic control.
Melanocortin receptor-4 agonist and glucagon-like peptide-1 receptor agonist synergistic obesity treatment
Administer to the patient a melanocortin receptor-4 agonist in a quantity sufficient to induce at least minimal weight loss when administered as a monotherapy not in conjunction with a glucagon-like peptide-1 receptor agonist, and a glucagon-like peptide-1 receptor agonist in a quantity sufficient to induce glycemic control but not weight loss when administered as a monotherapy not in conjunction with a melanocortin receptor-4 agonist, wherein the method elicits a synergistic effect on treatment of obesity.
Melanocortin receptor-4 agonist and glucagon-like peptide-1 receptor agonist synergistic glycemic control treatment
Administer to the patient a melanocortin receptor-4 agonist in a quantity sufficient to induce at least minimal weight loss when administered as a monotherapy not in conjunction with a glucagon-like peptide-1 receptor agonist and a glucagon-like peptide-1 receptor agonist in a quantity sufficient to induce glycemic control but not weight loss when administered as a monotherapy not in conjunction with a melanocortin receptor-4 agonist, wherein the method elicits a synergistic effect on treatment of glycemic control.
The claim set covers combination treatment in which each agent is used at quantities that define its monotherapy effect profile, and the therapeutic outcome depends on the synergistic effect produced by co-administration. Dependent claim refinements further specify sustained-release versus non-sustained-release formulations, duration-of-action constraints, and named GLP-1 receptor agonists and specific MC4 agonist peptide administration.
Stated Advantages
Synergistic effect on treatment of obesity.
Synergistic effect on treatment of glycemic control.
Documented Applications
Treating a patient with obesity by administering a melanocortin receptor-4 agonist together with a glucagon-like peptide-1 receptor agonist.
Treating a patient with obesity, diabetes or metabolic syndrome, including treatment of glycemic control using the synergistic combination.
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