# US 12,005,039 B2 · Methods and compositions relating to lipokines for treating metabolic disorders

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- Number: US 12,005,039 B2
- Document ID: US12005039B2
- Status: Granted
- Kind: B2
- Application number: 17/080,528
- Filed: 2020-10-26
- Published: 2021-06-03
- Granted: 2024-06-11
- Earliest claimed: 2018-04-27
- Assignees: Joslin Diabetes Center, Inc.
- Applicants: Joslin Diabetes Center, Inc.
- Inventors: Laurie J. Goodyear; Kristin Stanford
- Web page: https://patentgrep.com/patent/US12005039B2

## CPC

- A61K 31/201: having one or two double bonds, e.g. oleic, linoleic acids
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 21/06: Anabolic agents (androgens A61P5/26)
- 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

## Abstract

The invention includes methods and compositions for treating a metabolic disorder, such as metabolic syndrome, hyperlipidemia and associated disorders, such as obesity and diabetes. The invention includes a method of treating a human subject comprising administering 12,13-dihydroxy-9Z-octadecenoic acid (12,13-diHOME) to the subject. The invention also includes methods and compositions for treating disorders and conditions that would benefit from skeletal muscle fatty acid uptake and oxidation, increased mitochondrial respiration in skeletal muscle and/or enhanced exercise capacity.

## Claims

### Claim 1

A method of treating a human subject having a mitochondrial disorder or reducing severity of a symptom in a human subject having a mitochondrial disorder, said method comprising administering an effective amount of 12,13-dihydroxy-9Z-octadecenoic acid (12,13-diHOME), a stereoisomer, a geometric isomer, or a pharmaceutically acceptable salt thereof, to a subject having a mitochondrial disorder, wherein the mitochondrial disorder is selected from the group consisting of diabetes mellitus and deafness (DAD), Leber's hereditary optic neuropathy (LHON), Leigh syndrome, subacute sclerosing encephalopathy, neuropathy, ataxia, retinitis pigmentosa, and ptosis (NARP), myoneurogenic gastrointestinal encephalopathy (MNGIE), neuropathy, dementia, mitochondrial myopathy, myoclonic epilepsy with ragged red fibers (MERRF), progressive myoclonic epilepsy, mitochondrial myopathy, encephalomyopathy, lactic acidosis, stroke-like symptoms (MELAS), and mitochondrial neurogastrointestinal encephalomyopathy (MNGIE).

### Claim 2 (depends on 1)

The method of claim 1, wherein the symptom of the mitochondrial disorder is selected from the group consisting of poor growth, loss of muscle coordination, muscle weakness, visual and hearing problems, learning disabilities, heart disease, liver disease, kidney disease, gastrointestinal disorders, respiratory disorders, neurological problems, autonomic dysfunction and dementia.

### Claim 3

A method of treating a human subject having a condition associated with mitochondrial dysfunction, said method comprising administering an effective amount of 12,13-dihydroxy-9Z-octadecenoic acid (12,13-diHOME), a stereoisomer, a geometric isomer, or a pharmaceutically acceptable salt thereof, to a subject having Huntington's disease, Alzheimer's disease, Parkinson's disease, bipolar disorder, schizophrenia, aging and senescence, anxiety disorders, cardiovascular disease, cancer, diabetes, sarcopenia, or chronic fatigue syndrome; and wherein the effective amount of 12,13-diHOME is about 0.5 mg/kg to about 100 mg/kg.

### Claim 4 (depends on 3)

The method of claim 3, wherein the subject has type 2 diabetes.

### Claim 5 (depends on 3)

The method of claim 3, wherein the subject has cardiovascular disease.

### Claim 6 (depends on 3)

The method of claim 3, wherein the subject has sarcopenia.

### Claim 7

A method of treating a human subject having hypertriglyceridemia, said method comprising administering an effective amount of 12,13-diHOME, a stereoisomer, a geometric isomer, or a pharmaceutically acceptable salt thereof, to a subject having hypertriglyceridemia, wherein the effective amount of 12,13-diHOME is about 0.5 mg/kg to about 100 mg/kg.

### Claim 8

A method of treating a human subject having a disorder that would benefit from an increased level of metabolic activity, said method comprising administering an effective amount of 12,13-dihydroxy-9Z-octadecenoic acid (12,13-diHOME), a stereoisomer, a geometric isomer, or a pharmaceutically acceptable salt thereof, to a subject having obesity or type 2 diabetes; and wherein the effective amount of 12,13-diHOME is about 0.5 mg/kg to about 100 mg/kg.