Latest news with #CushingSyndrome
Yahoo
a day ago
- Business
- Yahoo
Corcept Therapeutics' Korlym Shows Glucose Control, Weight Reduction in Hypercortisolism, Type 2 Diabetes Patients
Corcept Therapeutics Incorporated (NASDAQ:CORT) is one of the best NASDAQ growth stocks to buy for the next 3 years. On June 24, Corcept Therapeutics announced positive results from the CATALYST trial of Korlym (mifepristone). The data was presented at the American Diabetes Association's 85th Scientific Sessions and also published in Diabetes Care. It showed that Korlym improved glucose control in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes. The trial met its primary endpoint, as patients receiving Korlym experienced a 1.47% decrease in HbA1c from baseline, as compared to a 0.15% decrease in the placebo group. Those on a 900mg dose saw a 2.01% HbA1c improvement. Beyond blood sugar, Korlym also led to reductions in body weight (by 5.1 kg) and waist circumference (by 5.1 cm), even as patients reduced or stopped other glucose-lowering medications. A biologist in a lab coat studying a culture of cells to find a cure for metabolic disorders. The CATALYST trial is the largest to date investigating hypercortisolism in difficult-to-control type 2 diabetes. Its initial phase screened 1,057 patients and found that 24% had hypercortisolism, which made them eligible for the treatment phase. Corcept Therapeutics Incorporated (NASDAQ:CORT) discovers and develops medication for the treatment of severe endocrinologic, oncologic, metabolic, and neurologic disorders in the US. While we acknowledge the potential of CORT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
23-06-2025
- Health
- Yahoo
Corcept Presents Data from Treatment Phase of CATALYST Trial at American Diabetes Association's 85th Scientific Sessions with Simultaneous Publication in Diabetes Care
Treatment with a cortisol modulator significantly improves glucose control in patients with hypercortisolism and difficult-to-control diabetes, accompanied by reductions in body weight, waist circumference and glucose-lowering medications CATALYST's prevalence phase identified hypercortisolism in 24 percent of patients with difficult-to-control type 2 diabetes REDWOOD CITY, Calif., June 23, 2025--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today presented data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym® in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes at the American Diabetes Association's 85th Scientific Sessions. CATALYST met its primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c (HbA1c), which decreased 1.47 percent from baseline, compared to a 0.15 percent decrease in patients who received placebo (p-value: < 0.001). Of the 91 patients in the treatment group, 65 (71%) received at least 600mg of Korlym and 28 (31%) received 900mg. Patients who received 900mg of Korlym had an improvement in HbA1c of 2.01 percent, compared to a 0.16 percent decrease in patients who received placebo (p-value: < 0.001). The trial also met its secondary endpoints, as patients who received Korlym exhibited significantly reduced body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002), compared to patients who received placebo. Patients receiving Korlym achieved these improvements despite reducing or discontinuing their glucose-lowering medications. Adverse events in CATALYST were manageable and consistent with Korlym's known safety profile. The most common adverse events (> 20% of participants receiving Korlym) were hypokalemia, fatigue and nausea. The conference presentations can be found here. Results were published simultaneously in Diabetes Care, in an article titled "Inadequately Controlled Type 2 Diabetes and Hypercortisolism: Improved Glycemia With Mifepristone Treatment." CATALYST is the largest and most rigorous trial ever conducted to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and assess the effect of treating patients found to have hypercortisolism with a cortisol modulator. The initial prevalence phase of the trial screened 1,057 patients with difficult-to-control type 2 diabetes (i.e., patients with HbA1c greater than 7.5 percent despite receiving multiple glucose-lowering medications, including best-in-class therapies such as GLP-1 agonists) at 36 sites in the United States. Based on results from a standard 1-mg dexamethasone suppression test, 24 percent of the patients screened were found to have hypercortisolism and were eligible to enter the trial's treatment phase, where they were randomized, 2:1, to receive either Korlym or placebo for 24 weeks. One hundred thirty-six patients enrolled in the treatment phase. "Many people with type 2 diabetes do not respond adequately to conventional glucose-lowering therapies," said John Buse, M.D., Ph.D., director of the University of North Carolina's Diabetes Center. "CATALYST shows that these patients should be screened for hypercortisolism and that treatment with a cortisol-directed therapy can confer significant clinical benefits, including meaningful reductions in HbA1c, body weight and waist circumference. These powerful findings provide important guidance for physicians treating patients with difficult-to-control type 2 diabetes." "We urgently need all physicians, not just endocrinologists, to develop a greater understanding of Cushing's syndrome," said Leslie Edwin, President of the Cushing's Support & Research Foundation. "As a person who has lived with the complex and far-reaching effects of Cushing's syndrome for almost two decades, it is difficult to see that some things have been slow to change. Patients are still spending years on average searching for the cause of deceptively common symptoms, like elevated blood sugar, weight gain, depression and anxiety treated as individual diagnoses instead of parts of a bigger, more burdensome problem that carries tremendous health risk. The CATALYST data will help physicians identify and treat patients more quickly and accurately through earlier screening, and that is such an exciting prospect for all of us in the Cushing's community." "The CATALYST results will help physicians more accurately diagnose and treat people with hypercortisolism, a serious and deadly disease that too often goes undetected," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "One in four patients with difficult-to-control type 2 diabetes have hypercortisolism and treatment with a cortisol modulator can be highly effective in improving many of their signs and symptoms. Corcept is thankful to the patients who participated in CATALYST. We hope these data can help all patients with this disease." About Hypercortisolism (Cushing's Syndrome) Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. IMPORTANT LIMITATIONS OF USE Do not use for the treatment of type 2 diabetes mellitus unrelated to endogenous Cushing's syndrome. BOXED WARNING: TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential. DOSAGE AND ADMINISTRATION Obtain a negative pregnancy test prior to initiating treatment with Korlym in females of reproductive potential, or if treatment is interrupted for more than 14 days. Administer once daily orally with a meal. The recommended starting dose is 300 mg once daily. Renal impairment: Do not exceed 600 mg once daily. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment. Based on clinical response and tolerability, the dose may be increased in 300-mg increments to a maximum of 1200 mg once daily. Do not exceed 20 mg/kg per day. Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 900 mg per day if clinically indicated. When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: for patients receiving a daily dose of 600 mg, reduce dose to 300 mg. For patients receiving a daily dose of 900 mg, reduce dose to 600 mg. For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor. CONTRAINDICATIONS Pregnancy; patients taking simvastatin or lovastatin and CYP3A substrates with narrow therapeutic ranges; patients receiving systemic corticosteroids for lifesaving purposes; women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma; patients with known hypersensitivity to mifepristone or to any of the product components. WARNINGS AND PRECAUTIONS Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency. Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if the patient also has a hemorrhagic disorder or is on anticoagulant therapy. QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval. Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Adjust Korlym dose as described in Dosage and Administration. Use only when necessary and do not exceed a Korlym dose of 900 mg. ADVERSE REACTIONS Most common adverse reactions in Cushing's syndrome (≥20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, endometrial hypertrophy. DRUG INTERACTIONS Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Adjust Korlym dose as described in Dosage and Administration. Use only when necessary, and do not exceed a Korlym dose of 900 mg. CYP3A inducers: Do not use Korlym with CYP3A inducers. Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym. Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz. Hormonal contraceptives: Do not use with Korlym. USE IN SPECIFIC POPULATIONS Lactation: Mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym®, relacorilant, miricorilant, dazucorilant and our other product candidates; those molecules' clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include: the impact of CATALYST on the medical field's practices regarding the screening for and treatment of hypercortisolism. We disclaim any intention or duty to update forward-looking statements made in this press release. View source version on Contacts Investor inquiries:ir@ Media inquiries:communications@ Sign in to access your portfolio
Yahoo
29-01-2025
- Entertainment
- Yahoo
Amy Schumer recalls awkward Bradley Cooper comment that bruised her ego
Amy Schumer has recalled a recent encounter with Bradley Cooper that left her feeling worse for wear. During a Tuesday (January 28) appearance on The Tonight Show Starring Jimmy Fallon to promote her new movie Kind of Pregnant, Schumer, 43, was asked to recount her hilarious run-in with the Maestro star. The Trainwreck actor happily obliged, setting the scene. 'So I saw him, and you know [ask], 'How are you?' and he said, 'You know, I turn 50 this year,' and he goes, 'You 50?'' Schumer shared. Looking out into the audience with a concerned expression, she continued: 'You know, I tried to recover. Because whatever I'm 43, but like I will be 50, but I'm not 50 yet.' She quipped: 'Yeah, no I'm not, Bradley. But thank you for thinking of me. But look, we all want to be hot! 'This is how bad people want to be hot. People literally run,' Schumer said flabbergasted, putting her hand to her heart. Getting up out of her chair to mimic runners, she shouted: 'Somebody have sex with me!' 'It's disgusting!' she joked. 'They're riding a bike to nowhere to the Wicked soundtrack? It's pathetic.' Schumer, who last February was diagnosed with Cushing Syndrome, currently leads Netflix's new rom-com Kinda Pregnant, coming out on February 5. In the film, the actor stars as Lainey, a woman who has dreams of settling down soon with a family. However, when she finds out her best friend is pregnant, she becomes jealous and begins to wear a fake pregnancy belly. Kinda Pregnant also stars Will Forte, Ginny and Georgia's Brianne Howey and Jillian Bell (Brittany Runs a Marathon). During a recent appearance on the Call Her Daddy podcast, Schumer opened up about how abuse from internet trolls about her appearance led to her Cushing Syndrome diagnosis. 'Doctors were chiming in, in the comments and they were, like, 'No, no … something's really up. Your face looks so crazy,' Schumer said. Cushing's Syndrome is a curable disorder that occurs when the body produces too much of the hormone cortisol. 'This can result from the body making too much cortisol, or from taking medicines called glucocorticoids, which affect the body the same way as cortisol,' according to Mayo Clinic. Symptoms can include weight gain in the backside and face, stretch marks (specifically on the stomach, hips, breasts, arms, and thighs), easily bruised skin, acne, slow skin healing, and a 'fatty lump between the shoulders,' Mayo Clinic adds.
The Independent
29-01-2025
- Entertainment
- The Independent
Amy Schumer recalls awkward Bradley Cooper comment that bruised her ego
Amy Schumer has recalled a recent encounter with Bradley Cooper that left her feeling worse for wear. During a Tuesday (January 28) appearance on The Tonight Show Starring Jimmy Fallon to promote her new movie Kind of Pregnant, Schumer, 43, was asked to recount her hilarious run-in with the Maestro star. The Trainwreck actor happily obliged, setting the scene. 'So I saw him, and you know [ask], 'How are you?' and he said, 'You know, I turn 50 this year,' and he goes, 'You 50?'' Schumer shared. Looking out into the audience with a concerned expression, she continued: 'You know, I tried to recover. Because whatever I'm 43, but like I will be 50, but I'm not 50 yet.' She quipped: 'Yeah, no I'm not, Bradley. But thank you for thinking of me. But look, we all want to be hot! 'This is how bad people want to be hot. People literally run,' Schumer said flabbergasted, putting her hand to her heart. Getting up out of her chair to mimic runners, she shouted: 'Somebody have sex with me!' 'It's disgusting!' she joked. 'They're riding a bike to nowhere to the Wicked soundtrack? It's pathetic.' Schumer, who last February was diagnosed with Cushing Syndrome, currently leads Netflix's new rom-com Kinda Pregnant, coming out on February 5. In the film, the actor stars as Lainey, a woman who has dreams of settling down soon with a family. However, when she finds out her best friend is pregnant, she becomes jealous and begins to wear a fake pregnancy belly. Kinda Pregnant also stars Will Forte, Ginny and Georgia 's Brianne Howey and Jillian Bell (Brittany Runs a Marathon). During a recent appearance on the Call Her Daddy podcast, Schumer opened up about how abuse from internet trolls about her appearance led to her Cushing Syndrome diagnosis. 'Doctors were chiming in, in the comments and they were, like, 'No, no … something's really up. Your face looks so crazy,' Schumer said. Cushing's Syndrome is a curable disorder that occurs when the body produces too much of the hormone cortisol. 'This can result from the body making too much cortisol, or from taking medicines called glucocorticoids, which affect the body the same way as cortisol,' according to Mayo Clinic. Symptoms can include weight gain in the backside and face, stretch marks (specifically on the stomach, hips, breasts, arms, and thighs), easily bruised skin, acne, slow skin healing, and a 'fatty lump between the shoulders,' Mayo Clinic adds.
