# US 11,433,042 B2 · Methods and compositions for treating metabolic disorders

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- Number: US 11,433,042 B2
- Document ID: US11433042B2
- Status: Granted
- Kind: B2
- Application number: 16/532,114
- Filed: 2019-08-05
- Published: 2020-01-23
- Granted: 2022-09-06
- Earliest claimed: 2017-02-06
- Assignees: Joslin Diabetes Center, Inc.
- Applicants: Joslin Diabetes Center, Inc.
- Inventors: Yu-Hua Tseng; Matthew Lynes
- Web page: https://patentgrep.com/patent/US11433042B2

## CPC

- A61K 31/201: having one or two double bonds, e.g. oleic, linoleic acids
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/06: Antihyperlipidemics
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- G01N 33/92: involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)}
- G01N 2800/04: Endocrine or metabolic disorders
- G01N 2800/32: Cardiovascular disorders
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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. Further provided is the use of 12,13-diHOME as a biomarker for identifying brown adipose tissue (BAT) activation in human subjects.

## Claims

### Claim 1

A method of detecting a 12,13-diHOME level in a human subject to determine whether the human subject has brown adipose tissue activation, said method comprising
a) obtaining a plasma sample from the human subject;
b) detecting a 12,13-diHOME level in the plasma sample; and
c) comparing the 12,13-diHOME level with a known baseline of plasma 12,13-diHOME level,
such that it is determined whether the human subject has brown adipose tissue activation.

### Claim 2 (depends on 1)

The method of claim 1, wherein the 12,13-diHOME levels in the plasma sample are detected using mass spectrometry.

### Claim 3 (depends on 1)

The method of claim 1, wherein the known baseline level of plasma 12,13-diHOME level is 0.2 pmol/mL.

### Claim 4

A method of determining whether a human subject has brown adipose tissue (BAT) activation, said method comprising determining the level of 12,13-diHOME in a plasma sample from the human subject, wherein a plasma 12,13-diHOME level of 0.2 pmol/mL or greater indicates BAT activation.

### Claim 5 (depends on 4)

The method of claim 4, wherein the level of 12,13-diHOME is determined using mass spectrometry.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject has a metabolic disorder or heart disease.

### Claim 7 (depends on 6)

The method of claim 6, wherein the metabolic disorder is selected from the group consisting of hyperlipidemia, insulin resistance, metabolic syndrome, obesity, and diabetes.

### Claim 8 (depends on 4)

The method of claim 4, wherein the human subject has at least one of the following characteristics
a) a plasma alanine transaminase (ALAT) level greater than 0.6 μkat/l;
b) a Body Mass Index (BMI) of 30 or more;
c) a Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score of 1.9 or more;
d) a plasma triglyceride level greater than 1.7 mmol/l;
e) a plasma aspartate transaminase (ASAT) level of greater than 0.3 μkat/l for a male subject or a plasma ASAT level of greater than 0.6 μkat/l for a female subject;
f) a plasma leptin level of 40 ng/ml or more; or
g) a plasma gGT level of 0.9 μkat/l or greater for a male subject or a plasma gGT level of 0.6 μkat/l or greater for a female subject.