# US 2022/0160622 A1 · Therapeutic methods involving gastrointestinal implants > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2022/0160622 A1 - Document ID: US20220160622A1 - Status: Published application - Kind: A1 - Application number: 17/529,544 - Filed: 2021-11-18 - Published: 2022-05-26 - Earliest claimed: 2016-12-12 - Assignees: GI Dynamics, Inc. - Applicants: GI Dynamics, Inc. - Inventors: Scott Schorer - Web page: https://patentgrep.com/patent/US20220160622A1 ## CPC - A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)} - A61P 3/04: Anorexiants; Antiobesity agents - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/0031: {Rectum, anus} - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 31/403: condensed with carbocyclic rings, e.g. carbazole - A61K 31/4985: Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems - A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir - A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06) - A61K 35/76: Viruses; Subviral particles; Bacteriophages - A61K 38/26: Glucagons - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract The present invention provides combination therapies for treating a metabolic disorder, such as type 2 diabetes, obesity, and related comorbidities (e.g., NASH or NAFLD)) in an individual undergoing treatment with a gastrointestinal implant. The combination therapies described herein include methods for treating an individual with a gastrointestinal implant with a metabolic agent, a bariatric procedure, and/or a microbiota modulator. ## Claims ### Claim 1 A method of treating a metabolic disorder in an individual undergoing treatment with a gastrointestinal implant, the method comprising administering one or more metabolic agents to the individual in an amount and for a duration to treat the metabolic disorder. ### Claim at position 2 2-22. (canceled) ### Claim 23 A method of treating a metabolic disorder in an individual undergoing treatment with a gastrointestinal implant, the method comprising performing one or more bariatric procedures to treat the metabolic disorder. ### Claim at position 4 24-30. (canceled) ### Claim 31 A method of treating a metabolic disorder in an individual undergoing treatment with a gastrointestinal implant, the method comprising administering one or more microbiota modulators to an individual in an amount and for a duration to treat the metabolic disorder. ### Claim at position 6 32-52. (canceled) ### Claim 53 (depends on 1) The method of claim 1, wherein the one or more metabolic agents comprises an incretin modulator, wherein the incretin modulator is a glucagon-like peptide-1 (GLP-1) receptor agonist and/or a dipeptidyl peptidase-4 (DPP-4) inhibitor. ### Claim 54 (depends on 53) The method of claim 53, wherein: (a) the GLP-1 receptor agonist is liraglutide, exenatide, lixisenatide, dulaglutide, or albiglutide; and/or (b) the DPP-4 inhibitor is sitagliptin, saxagliptin, alogliptin, or linagliptin. ### Claim 55 (depends on 1) The method of claim 1, wherein the one or more metabolic agents is administered prior to treatment with the gastrointestinal implant or during treatment with the gastrointestinal implant. ### Claim 56 (depends on 23) The method of claim 23, wherein the one or more bariatric procedures comprises a restrictive bariatric procedure comprising: (a) providing a space-occupying device to an individual, wherein the space-occupying device is an intragastric balloon; or (b) a gastroplasty procedure, wherein the gastroplasty procedure comprises placing transmural tissue anchor plications in the gastric fundus and body. ### Claim 57 (depends on 31) The method of claim 31, wherein the one or more gastrointestinal microbiota modulators comprises: (a) treatment with one or more species of bacteria; or (b) treatment with one or more bacteriophage. ### Claim 58 (depends on 57) The method of claim 57, wherein the treatment with one or more species of bacteria is provided by a fecal microbiota transplant. ### Claim 59 (depends on 31) The method of claim 31, wherein the one or more gastrointestinal microbiota modulators comprises: (a) a prescribed diet regimen, wherein the prescribed diet regimen comprises a food enriched in one or more polyphenols, saccharides, polysaccharides, peptides, polypeptides, lipids, or any combination thereof or a food enriched in one or more species of bacteria; or (b) a dietary supplement, wherein the dietary supplement is a prebiotic supplement or a probiotic supplement, wherein the prebiotic supplement comprises a polyphenol, saccharide, polysaccharide, peptide, polypeptide, lipid, or any combination thereof. ### Claim 60 (depends on 31) The method of claim 31, wherein the one or more gastrointestinal microbiota modulators is administered prior to treatment the gastrointestinal implant or during treatment with the gastrointestinal implant, wherein the one or more gastrointestinal microbiota modulators is an agent that increases survival of beneficial gastrointestinal microbiota of the individual or modifies a composition of pathogenic gastrointestinal microbiota of the individual. ### Claim 61 (depends on 31) The method of claim 31, the method further comprising performing one or more bariatric procedures to treat the metabolic disorder. ### Claim 62 (depends on 31) The method of claim 31, wherein the metabolic disorder is type 2 diabetes, obesity, non-alcoholic steatohepatitis (NASH), or non-alcoholic fatty liver disease (NAFLD).