The landmark STEP 1 extension trial, published in Diabetes, Obesity and Metabolism (2022), followed participants after withdrawal of semaglutide 2.4 mg
Who should be cautious: Anyone sensitive to spicestart with a very small amount of ginger or leave it out entirely
The TL:DR (Too Long
Sensory nerve damage produces the symptoms most people associate with neuropathy: numbness, tingling, burning pain, pins-and-needles sensations, and hypersensitivity to touch
You may be eligible to participate if you are 18 or older and have: Been diagnosed with painful diabetic peripheral neuropathy or report pain that is consistent with a diagnosis and has been going on for at least three months Been diagnosed with type 2 diabetes at least six months prior to screening Been taking any diabetes or pain medications that you are using regularly for at least three months prior to screening An A1C of 6.0-10.5% at screening A BMI greater than 25 Women who are pregnant, breastfeeding, or planning to become pregnant are not eligible to participate
Placebo at 24 weeks Nausea incidence / most common AE / 40.4% in the Phase 3 RECONNECT trial at the approved 1.75 mg dose FDA approval year / Vyleesi / approved June 2019 for premenopausal women with HSDD Contraindication / cardiovascular disease / avoid in patients with known CV disease due to pressor effect Reporting / adverse events / call Poison Control 1-800-222-1222 or go to the nearest emergency department What PT-141 (Bremelanotide) Is and How It Works PT-141, sold as Vyleesi, is a cyclic heptapeptide melanocortin receptor agonist approved by the FDA in June 2019 for hypoactive sexual desire disorder (HSDD) in premenopausal women
