Granted Patent
B2
US 12,295,988 · App. 18/820,792 · Granted May 13, 2025
Semaglutide in medical therapy
Inventors:
Lars Holm Damgaard (Herlev, DK); Soeren Oestergaard Hardt-Lindberg (Virum, DK); Thomas Hansen (Broenshoej, DK)
Assignee:
Novo Nordisk A/S
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Abstract
The present invention relates to semaglutide for use in weight management.
Claims (1)
1. A method for treating type 2 diabetes in a subject in need thereof, comprising administering semaglutide to the subject in an amount of 2.0 mg once weekly, wherein the semaglutide is administered subcutaneously.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 1, 2025
From: DAMGAARD, LARS HOLM; HARDT-LINDBERG, SOEREN OESTERGAARD
To: NOVO NORDISK A/S
Reel/Frame 070691/0627 →
Priority Claims (1)
EP 17196254
· Oct 12, 2017
· regional
Continuity (4)
Continuation
PCTEP2018077654
· Oct 10, 2018
References Cited (137)
US 6268343B1
· Knudsen et al.
· 2001
[cited by applicant]
US 7799344B2
· Oberg
· 2010
[cited by applicant]
US 8114833B2
· Pedersen et al.
· 2012
[cited by applicant]
US 8129343B2
· Lau et al.
· 2012
[cited by applicant]
US 8536122B2
· Lau et al.
· 2013
[cited by applicant]
US 8748376B2
· Ludvigsen et al.
· 2014
[cited by applicant]
US 8846618B2
· Flink et al.
· 2014
[cited by applicant]
US 9764003B2
· Jensen
· 2017
[cited by applicant]
US 20070203058A1
· Lau et al.
· 2007
[cited by applicant]
US 20100047762A1
· Button et al.
· 2010
[cited by applicant]
US 20100292133A1
· Spetzler et al.
· 2010
[cited by applicant]
US 20150232527A1
· Gong et al.
· 2015
[cited by applicant]
US 20160108102A1
· Lau et al.
· 2016
[cited by applicant]
US 20190231876A1
· Pedersen et al.
· 2019
[cited by applicant]
CN 102229668A
· 2011
[cited by applicant]
CN 104519902A
· 2015
[cited by applicant]
CN 108129565A
· 2018
[cited by applicant]
RU 2409349C2
· 2011
[cited by applicant]
RU 2413530C2
· 2011
[cited by applicant]
WO 2005027978A2
· 2005
[cited by applicant]
WO 2005049061A2
· 2005
[cited by applicant]
WO 2006097537A2
· 2006
[cited by applicant]
WO 2010092163A2
· 2010
[cited by applicant]
WO 2011080103A1
· 2011
[cited by applicant]
WO 2011138421A1
· 2011
[cited by applicant]
WO 12016419A1
· 2012
[cited by applicant]
WO 2012080471A1
· 2012
[cited by applicant]
WO 2012088379A2
· 2012
[cited by applicant]
WO 2012107476A1
· 2012
[cited by applicant]
WO 12130136A1
· 2012
[cited by applicant]
WO 2012136790A1
· 2012
[cited by applicant]
WO 2012177929A2
· 2012
[cited by applicant]
WO 2014005858A1
· 2014
[cited by applicant]
WO WO2014177683A1
· 2014
[cited by examiner]
WO 2017112824
· 2017
[cited by applicant]
Ahmann et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER after 56 Weeks in Subjects with Type 2 Diabetes (Sustain 3),” Diabetes Research and Clinical Practice, 2016, vol. 120, p. S51.
[cited by applicant]
Anonymous: “NCT02453711 on Jul. 26, 2017: ClinicalTrials.gov Archive,” Retrieved from Internet: URL:https://clincialtrials.gov/archive/NCT02453711/2017_07_26, retrieved on Jan. 26, 2018.
[cited by applicant]
Aroda et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Once-Daily Insulin Glargine in Insulin-Naive Subjects with Type 2 Diabetes (Sustain 4),” Diabetes Research and Clinical Practice, 2016, vol. 120, p. S…
[cited by applicant]
Blundell et al., “Effects of once-weekly Semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity,” Diabetes Obes Metab, 2017, vol. 19, pp. 1242-1251.
[cited by applicant]
Chow et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Sitagliptin as Add-On to Metformin and/or Thiazolidinediones in Subjects with T2D (Sustain 2),” Diabetes Research and Clinical Practice, 2016, vol. 120…
[cited by applicant]
Davies et al., “Dose-dependent glucose lowering and body weight reductions with the novel oral formulation of semaglutide in patients with early type 2 diabetes,” Abstract 149, Diabetologia, 2016, vol. 59, Suppl. 1, p. …
[cited by applicant]
Davies et al., “Effect of oral semaglutide compared with placebo and subcutaneous semaglutide on glycemic control in patients with type 2 diabetes,” JAMA, 2017, vol. 218, No. 15, pp. 1460-1470.
[cited by applicant]
Lingvay et al., “Treatment with semaglutide provides superior body weight reduction vs comparators in subjects with type 2 diabetes across the Sustain 1-5 trials,” Abstract 817, Diabetologia, 2017, vol. 60, Suppl. 1, p.…
[cited by applicant]
Nauck et al., “The once-weekly human GLP-1 analogue semaglutide provides significant reductions in HbA1c and body weight in patients with type 2 diabetes,” Abstract 2, Diabetologia, 2012, vol. 55, Suppl. 1, p. S7.
[cited by applicant]
Tan et al., “Efficacy and safety of once-weekly semaglutide for the treatment of type 2 diabetes,” Expert Opin Investig Drugs, 2017, vol. 26, No. 9, pp. 1083-1089.
[cited by applicant]
Nauck et al. “A phase 2, randomized, dose-finding study of the novel once-weekly human GLP-1 analog, semaglutide, compared with placebo and open-label liraglutide in patients with type 2 diabetes.” Diabetes care, Feb. 2…
[cited by applicant]
O'Neil et al. “Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial.” …
[cited by applicant]
Madsbad S et al. An Overview of once-weekly glucagon-like peptide-1 receptor agonists available efficacy and safety data and perspectives for the future, Diabetes, Obesity and Metabolism Year 2011, vol. 13, No. 5, pp. 3…
[cited by applicant]
Buse B. J. et al., Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (Duration-6): a randomised, open-label study, Lancet, 2013, vol. 381, pp. 117-124.
[cited by applicant]
Kim et al. “Effects of Once-Weekly Dosing of a Long-Acting Release Formulation of Exentide on Glucose Control and Body Weight in Subjects with Type 2 Diabetes.” Diabetes care (2007) vol. 30 pp. 1487-1493.
[cited by applicant]
Bydureon NDA 022200/S-008 Package Information pp. 1-179 (Feb. 2014).
[cited by applicant]
Clinical Trial NCT00696657 entitled “A Randomized Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide.” pp. Mar. 1-5, 2015. Accessed Sep. 24, 2015 at clinicaltrials.gov/archive/…
[cited by applicant]
Lau et al. “Discovery of the Once-WEekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.” J. Med. Chem. (2015) vol. 58 pp. 7370-7380.
[cited by applicant]
Eperzan Assessment Report. Euro. Med. Agency. pp. 1-124 (2014) accessed Sep. 24, 2015 at URL ema.europa.ed/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002735/WC500165119.pdf.
[cited by applicant]
Trulicity Assessment Report. Euro. Med. Agency. pp. 1-172 (2014) accessed Sep. 24, 2015 at URL ema.europa.ed/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002825/WC500179473.pdf.
[cited by applicant]
Mizuta et al. “The Role for GLP-1 in Regulation of Body Weight.” Progress in Medicine 2008 vol 28 No. 8 pp. 1909-1912.
[cited by applicant]
CDC, “National Health and Nutrition Examination Survey: Healthy Weight, Overweight and Obesity among U.S. adults” 03-0260 pp. 1-2 (Jul. 2003), accessed May 10, 2016 at URL cdc.gov/nchs/data/nhanes/databriefs/adultweight…
[cited by applicant]
Application No. EP12/186,781, filed Oct. 1, 2012.
[cited by applicant]
Application No. EP12174535, filed Jul. 1, 2012.
[cited by applicant]
U.S. Appl. No. 61/694,837, filed Aug. 30, 2012.
[cited by applicant]
U.S. Appl. No. 61/708,162, filed Oct. 1, 2012.
[cited by applicant]
Astrup et al., “Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study.” Lancet, Nov. 2009, vol. 374, No. 9701, pp. 1606-1616.
[cited by applicant]
Astrup et al., “Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide.” Int J Obes (Lond). Jun. 2012, vol. 36, No. 6, pp. 843-854.
[cited by applicant]
Barnett et al., “Obesity and Diabetes”, John Wiley & Sons, Mar. 12, 2009, pp. 87-101.
[cited by applicant]
Cleland et al., Formulation and Delivery of Proteins and Peptides, vol. 567, Aug. 1994, Chapter 1, p. 5.
[cited by applicant]
Clinical trial: NCT00422058 “The Effect of Liraglutide on Body Weight in Obese Subjects 1I Without Diabetes” Jan. 2007, 1 Page.
[cited by applicant]
European Medicines Agency EPAR Assessment Report for Victoza, Liraglutide , 2009, p. 7 and p. 9.
[cited by applicant]
Examination Division Exam Dec. 12, 2006.
[cited by applicant]
Frokjaer et al.,“Pharmaceutical formulation development of peptides and proteins”, Jan. 2003, Chapter 8, p. 147.
[cited by applicant]
Full prosecution file of the opposed patent EP2866825B1 that can be found in European Patent register https://register.epo.org/applicationlng=en&tab=doclist&number=EP13737808&filter=ALL Accessed Jan. 25, 2021.
[cited by applicant]
Gibson, M., “Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection in Commercial Dosage Form”, Drugs and the Pharmaceutical Sciences, Informa Healthcare, 2009, vol. 199, p. 327.
[cited by applicant]
History of Changes for Study NCT00696657, ClinicalTrials.gov archive, Mar. 3, 2011.
[cited by applicant]
Novo Nordisk announcement Semaglutide 2.4mg for obesity 2020, “Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management” Dec. 4, 2020.
[cited by applicant]
Novo Nordisk Clinical trial report: NN8022-I 807 “Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes” Feb. 8, 2010 p. 34.
[cited by applicant]
Torekov et al., “Obesity-an indication for GLP-1 treatment?” Obesity pathophysiology and GIP-1 treatment potential, Obes Rev, Aug. 2011, vol. 12, No. 8, pp. 593-601.
[cited by applicant]
European Medicines Agency EPAR Ozempic, Semaglutide, Assessment Report, 2018 p. 11 and p. 21.
[cited by applicant]
Protocol of clinical trial NCT00696657 entitled A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide: Sep. 22, 2011, ClinicalTrials.gov archive, pp. 1-5.
[cited by applicant]
Yakushinyaku, “General Consideration for Clinical Evaluations of New Drugs”, Jun. 29, 1992, pp. 1-12.
[cited by applicant]
Kapitza et al., “Semaglutide, a Once-Weekly Human GLP-1 Analog, Does Not Reduce the Bioavailability of the Combined Oral Contraceptive, Ethinylestradiol/Levonorgestrel,” J Clin Pharmacol., May 2015, vol. 55, No. 5, pp. …
[cited by applicant]
Holst JJ., “The physiology of glucagon-like peptide 1,” Physiol Rev, Oct. 2007, vol. 87, No. 4, pp. 1409-1439.
[cited by applicant]
Lovshin et al., “Incretin-based therapies for type 2 diabetes mellitus”, Nature Reviews Endocrinology, May 2009, vol. 5, pp. 262-269.
[cited by applicant]
Baggio et al., “Biology of Incretins: GLP-1 and GIP,” Gastroenterology, 2007, vol. 132, pp. 2131-2157.
[cited by applicant]
Ahmann et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (Sustain 3): A 56-Week, Open-Label, Randomized Clinical Trial”, Diabetes Care, Dec. 2017, vol. 41, No. …
[cited by applicant]
Aroda et al., “Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (Sustain 4): a rando…
[cited by applicant]
Li Jun et al., “Peoples Medical Publishing House” Clinical pharmacology 4th Edition, Jun. 2008, pp. 31, 48-49.
[cited by applicant]
Saxenda, Full Prescribing Information, Sep. 2016, 28 pages.
[cited by applicant]
U.S. Appl. No. 62/541,260, filed Aug. 4, 2017, 98 pages.
[cited by applicant]
Ahrén et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Once-Daily Sitagliptin as an Add-on to Metformin, Thiazolidinediones, or Both, in Patients with Type 2 Diabetes (Sustain 2): A 56-Week Double-Blind, P…
[cited by applicant]
Bhansali et al., “Historical Overview of Incretin Based Therapies”, Journal of Association of Physicians of India, Jun. 2010, vol. 58, pp. 10-14.
[cited by applicant]
Carracher et al., “American Association of Diabetes Educators 2017”, Journal of Diabetes, Aug. 2017, pp. 1054-1057.
[cited by applicant]
Davies et al., “Efficacy of Liraglutide for Weight Loss Among Patients with Type 2 Diabetes the Scale Diabetes Randomized Clinical Trial”, Journal of the American Medical Association, Aug. 2015, vol. 314, No. 7, pp. 687…
[cited by applicant]
Drucker et al., “The Incretin System: Glucagon-Like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes”, Lancet, Nov. 2006, vol. 368, pp. 1696-1705.
[cited by applicant]
Holst et al., “Glucagon-Like Peptide 1 and Inhibitors of Dipeptidyl Peptidase IV in the Treatment of Type 2 Diabetes Mellitus”, Current Opinion in Pharmacology, Oct. 2004, vol. 4, pp. 589-596.
[cited by applicant]
Jensen et al., “Absorption, Metabolism and Excretion of the GLP-1 Analogue Semaglutide in Humans and Nonclinical Species”, European Journal of Pharmaceutical Sciences, Mar. 2017, vol. 104, pp. 31-41.
[cited by applicant]
Kalra et al., “Glucagon-like Peptide-1 Receptor Agonists in the Treatment of Type 2 Diabetes: Past, Present, and Future”, Indian Journal of Endocrinology & Metabolism, Mar.-Apr. 2016, vol. 20, No. 2, pp. 254-267.
[cited by applicant]
Kapitza et al., “Safety, Tolerability, Pharmacokinetics (PK) / Pharmacodynamics (PD) of Single Escalating Doses of Semaglutide, A Unique Once Weekly GLP-1 Analogue, in Healthy Male Subjects”, Diabetologia, 2012, vol. 55…
[cited by applicant]
Lund et al., “Glucagon-Like Peptide-1 Receptor Agonists for the Treatment of Type 2 Diabetes: Differences and Similarities”, European Journal of Internal Medicine, Mar. 2014, vol. 25, pp. 407-414.
[cited by applicant]
Marso et al., “Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes”, The New England Journal of Medicine, 16 Sep. 2016, vol. 375, No. 19, pp. 1834-1844.
[cited by applicant]
Monami et al., “Effects of Glucagon-Like Peptide-1 Receptor Agonists on Body Weight: A Meta-Analysis”, Experimental Diabetes Research, 2012, pp. 1-8.
[cited by applicant]
Nauck et al., “Incretin-Based Therapies”, Diabetes Care, Nov. 2009, vol. 32, Supplement 2, pp. S223-S231.
[cited by applicant]
NCT01272232, “Effect of Liraglutide on Body Weight in Overweight or Obese Subjects with Type 2 Diabetes: Scale™ —Diabetes”, May 2011, 4 pages.
[cited by applicant]
NCT03144271, “Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects”, May 2017, 9 pages.
[cited by applicant]
NCT02461589, “Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes”, Oct. 2017, 11 pages.
[cited by applicant]
Novo Nordisk 2016 Form 6-K, Feb. 9, 2017, 124 pages.
[cited by applicant]
Novo Nordisk Press Release, “Novo Nordisk reports up to 13.8% weight loss in people with obesity receiving semaglutide in phase 2 trial”, Jun. 23, 2017, 2 pages.
[cited by applicant]
Novo Nordisk, “Investor Presentation—First 6 months of 2017”, 2017, 110 pages.
[cited by applicant]
Novo Nordisk R&D Pipeline, “Semaglutide”, 2010, 3 pages.
[cited by applicant]
Ozempic Label, Highlights of Prescribing Information, Nov. 2024.
[cited by applicant]
Peterson et al., “Glucose Dysregulation and Response to Common Anti-diabetic Agents in the FATZO/Pco Mouse”, PLOS One, Jun. 2017, pp. 1-19.
[cited by applicant]
Pi-Sunyer et al., “A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management”, New England Journal of Medicine, Jul. 2015, vol. 373, No. 1, pp. 11-22.
[cited by applicant]
Smith, “Summary Review for Regulatory Action—Saxenda ”, Center for Drug Evaluation and Research, Nov. 2014, pp. 1-37.
[cited by applicant]
Sorli et al., “Efficacy and Safety of Once-Weekly Semaglutide Monotherapy Versus Placebo in Patients with Type 2 Diabetes (Sustain 1): A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multinational, Multi…
[cited by applicant]
Victoza Label, Highlights of Prescribing Information, Jan. 2010.
[cited by applicant]
Vilsboll et al., “Liraglutide, a Long-Acting Human Glucagon-Like Peptide-1 Analog, Given as Monotherapy Significantly Improves Glycemic Control and Lowers Body Weight Without Risk of Hypoglycemia in Patients with Type 2…
[cited by applicant]
Bode et al., “10-Fold Liraglutide Overdose Over 7 Months Resulted Only in Minor Side-Effects”, Journal of Clinical Pharmacology, 2013, vol. 53, No. 7, pp. 785-786.
[cited by applicant]
Davies et al., “Supplemental Online Content, Efficacy of Liraglutide for Weight Loss Among Patients with Type 2 Diabetes the Scale Diabetes Randomized Clinical Trial”, Journal of the American Medical Association, 2015, …
[cited by applicant]
Drugs at FDA Adlyxin, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=208471, 2 pages.
[cited by applicant]
Drugs at FDA Byduryeon, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022200, 3 pages.
[cited by applicant]
Drugs at FDA Ozempic, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209637, 2 pages.
[cited by applicant]
Drugs at FDA Saxenda, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206321, 3 pages.
[cited by applicant]
Drugs at FDA Tanzeum, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125431, 2 pages.
[cited by applicant]
Drugs at FDA Trulicity, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125469, 3 pages.
[cited by applicant]
Drugs at FDA Victoza, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022341, 4 pages.
[cited by applicant]
Elmehdawi et al., “An Accidental Liraglutide Overdose: Case Report”, Libyan Journal of Medicine, 2014, vol. 9, p. 1.
[cited by applicant]
Jimenez-Solem et al., “Dulaglutide, a Long-Acting GLP-1 Analog Fused with an Fc Antibody Fragment for the Potential Treatment of Type 2 Diabetes”, Current Opinion in Molecular Therapeutics, 2010, vol. 12, No. 6, pp. 790…
[cited by applicant]
Nakanishi et al., “Attempted Suicide with Liraglutide Overdose Did Not Induce Hypoglycemia”, Diabetes Research & Clinical Practice, Nov. 2012, vol. 99, p. e3-e4.
[cited by applicant]
Novo Nordisk, “Investor presentation First 9 months of 2016”, 2016, 113 pages.
[cited by applicant]
American Diabetes Association, “Standards of Medical Care in Diabetes”, Diabetes Care, Jan. 2004, vol. 27, Supplement 1, pp. S15-S35.
[cited by applicant]
American Diabetes Association, “Standards of Medical Care in Diabetes”, Diabetes Care, Jan. 2010, vol. 33, Supplement 1, pp. S11-S61.
[cited by applicant]
UK Prospective Diabetes Study (UKPDS) Group, “Effect of Intensive Blood-Glucose Control with Metformin on Complications in Overweight Patients with Type 2 Diabetes (UKPDS 34)”, Lancet, Sep. 1998, vol. 352, pp. 854-865.
[cited by applicant]
Victoza Label, Highlights of Prescribing Information, Aug. 2017.
[cited by applicant]
Cited By (1)