Methods for treating metabolic disorders and obesity with gip and glp-1 receptor-active glucagon-based peptides

Inactive Publication Date: 2016-06-23
MARCADIA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010]One aspect of the invention provides methods for reducing weight gain or inducing weight loss in an adult human in need thereof (e.g., the adult human has excess body weight, diabetes mellitus type II, insulin resistance, alcoholic liver disease, non-alcoholic fatty liver disea

Problems solved by technology

Despite the use of multiple drugs, however, the

Method used

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  • Methods for treating metabolic disorders and obesity with gip and glp-1 receptor-active glucagon-based peptides
  • Methods for treating metabolic disorders and obesity with gip and glp-1 receptor-active glucagon-based peptides
  • Methods for treating metabolic disorders and obesity with gip and glp-1 receptor-active glucagon-based peptides

Examples

Experimental program
Comparison scheme
Effect test

example 1

Extended Half-Life GLP-1 / GIP Coagonist Peptide was Well Tolerated with an Extended Half-Life of about 5 Days

[0152]A Phase I, randomized, placebo-controlled, sequential, single-ascending, two period, study was performed in healthy male subjects to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) properties of extended half-life GLP-1 / GIP coagonist peptide. Healthy adult male subjects (about 18 to 55 years of age) who were in general good health based on medical history, physical examination, ECG, and routine laboratory tests (e.g., blood, chemistry, hematology, urinalysis, and drug screen) with a body mass index between 20 kg / m2 and 30 kg / m2 were selected for the study. The extended half-life GLP-1 / GIP coagonist peptide tested in all of the Examples was SEQ ID NO: 153.

[0153]The subjects were randomized into cohorts. Cohort 1, 2, 3, 4, 5, and 6 each consisted of 6 patients that received 0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, and 8 mg, respectively of the ex...

example 2

Extended Half-Life GLP-1 / GIP Coagonist Peptide Increased Insulin Secretion in a Dose-Dependent Manner

[0159]A Phase I, randomized, placebo-controlled, positive-controlled two-part study was performed in healthy male and female subjects to evaluate the effect of a range of doses on beta cell response to a glucose load and to assess the effect of these doses on gastric emptying. Beta cell function was assessed by calculation of prehepatic insulin secretion in response to a graded glucose infusion. Gastric emptying was assessed by measurement of plasma appearance of ingested acetaminophen.

[0160]Subjects in Part 1 (Cohort 1) received two subcutaneous (SC) injections of placebo, 2 hours apart, in the abdomen on Day 1, followed by two 5 μg subcutaneous (SC) injections of BYETTA (Amylin Pharmaceuticals), 2 hours apart (10 μg total) in the abdomen on Day 2. During Part 2, subjects in Cohort 2 received placebo on Day 1, followed by 8 mg of the extended half-life GLP-1 / GIP coagonist peptide on...

example 3

Effect of Extended Half-Life GLP-1 / GIP Coagonist Peptide in Patients with Type II Diabetes Mellitus

[0177]A randomized, placebo-controlled, sequential, multiple-ascending dose study is performed on male and female patients (18 to 70 years of age) diagnosed with type 2 diabetes and on stable metformin monotherapy (i.e., at the same dose for at least about 2 months prior to the study), with an HbA1c level of at least about 6.5% and no more than 10.5%. Other criteria include fasting glucose levels of 110 mg / dL to 200 mg / dL, body mass index of 27 kg / m2 to 40 kg / m2, systolic blood pressure less than 155 mmHg, diastolic blood pressure less than 95 mmHg and no history of significant other disease or complications.

[0178]The patients are randomized into 4 cohorts. Cohort 1 consists of 8 patients that receive 4 mg of the extended half-life GLP-1 / GIP coagonist peptide and 2 patients that receive placebo. Cohort 2 consists of 8 patients that receive 12 mg of the extended half-life GLP-1 / GIP coag...

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Abstract

Methods are provided for administering an extended half-life GLP-1/GIP coagonist peptide to a patient in need thereof for reducing weight gain, inducing weight loss, treating hyperglycemia, reducing blood glucose levels, or normalizing blood glucose levels in said patient.

Description

PRIORITY CLAIM[0001]This application is a divisional of U.S. patent application Ser. No. 13 / 996,937, a U.S. national stage application of International Application No. PCT / US11 / 66739, filed Dec. 22, 2011, now U.S. Pat. No. 8,975,223, which claims priority to U.S. Provisional Application No. 61 / 500,229, filed Jun. 23, 2011, and U.S. Provisional Application No. 61 / 426,338, filed Dec. 22, 2010. The contents of each of these applications are incorporated herein by reference.INCORPORATION BY REFERENCE OF MATERIAL SUBMITTED ELECTRONICALLY[0002]Incorporated by reference in its entirety is a computer-readable nucleotide / amino acid sequence listing submitted concurrently herewith and identified as follows: One 285,688 byte ASCII (Text) file named “45708A_SeqListing.txt,” created on Dec. 22, 2011.BACKGROUND OF THE INVENTION[0003]1. Field of the Disclosure[0004]This disclosure relates generally to methods of administering an extended half-life GLP-1 / GIP coagonist peptide. More particularly, th...

Claims

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Application Information

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IPC IPC(8): A61K38/26A61K47/48A61K9/00A61K38/17A61K45/06
CPCA61K38/26A61K38/17A61K47/48215A61K9/0019A61K45/06A61K31/195A61K31/198A61K47/60A61P1/16A61P3/00A61P3/04A61P3/10A61P43/00A61K2300/00A61K9/0021
Inventor VIGNATI, LOUISDIMARCHI, RICHARD D.
Owner MARCADIA BIOTECH
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