Hypoglycemia

• REDWOOD CITY, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that a poster titled “An Analysis of Overnight Hypoglycemia in Patients with Congenital Hyperinsulinism: Results from the RZ358-606 (RIZE) Study” will be presented at the Pediatric Endocrine Society (PES) Annual Meeting, to be held May 2-5, 2024 at the Sheraton Grand Chicago Riverwalk.
• Paul Thorton, M.D., of Cook Children’s Medical Center in Fort Worth, Texas, will present the poster, which details findings from the Company’s Phase 2 RIZE study evaluating the treatment of congenital hyperinsulinism (HI) with RZ358 in pediatric patients.
• A Phase 3 study is currently underway.
• For more information on the conference presentation schedule and to view the poster abstract, please visit the PES Annual Meeting website .

• Panelists will discuss the complexity of digital systems required to continuously monitor symptoms, signs, and digital biomarkers in this diverse patient population.
• Another key topic with cardiometabolic clinical trials is compliance and dropouts.
• Hypoglycemia needs to trigger an e-diary and all data should be available in real time to sponsors and clinical research organizations.
• To capture all these data in a single system Clinical ink has developed GlucoseReadyTM, an integrated GCP compliant digital platform.

• Recently, CMS proposed the addition of two new mandatory electronic clinical quality measures (eCQMs) related to Severe Hypoglycemia and Severe Hyperglycemia for the CY 2026 reporting period.
• The proposed rule change issued on April 10, 2024, impacts hospitals through the Hospital Inpatient Quality Reporting (IQR) program.
• We are proud to align with industry experts, partners, clients, and CMS in supporting measures to advance diabetes care, reduce health inequities, and move beyond antiquated, paper-based solutions."
• The mandatory measures are related to glucose and diabetes management, which have been significant challenges for the healthcare industry.

• Hundreds of thousands of people worldwide are taking drugs like Ozempic to lose weight.
• As demand for semaglutide increases, so are claims that taking it is “cheating” at weight loss or the “easy way out”.
• We don’t tell people who need statin medication to treat high cholesterol or drugs to manage high blood pressure they’re cheating or taking the easy way out.

How does it work?

• GLP-1 gets secreted by cells in your gut when it detects increased nutrient levels after eating.
• GLP-1 receptor agonist (GLP-1RA) medications like Ozempic help the body’s own GLP-1 work better by mimicking and extending its action.
• Read more:
  The rise of Ozempic: how surprise discoveries and lizard venom led to a new class of weight-loss drugs

What can users expect? What does the research say?

• Higher doses of semaglutide are prescribed to treat obesity compared to type 2 diabetes management (up to 2.4mg versus 2.0mg weekly).
• A large group of randomised controlled trials, called STEP trials, all tested weekly 2.4mg semaglutide injections versus different interventions or placebo drugs.
• Trials lasting 1.3–2 years consistently found weekly 2.4 mg semaglutide injections led to 6–12% greater weight loss compared to placebo or alternative interventions.

• Weight reduction due to semaglutide also leads to a reduction in systolic and diastolic blood pressure of about 4.8 mmHg and 2.5 mmHg respectively, a reduction in triglyceride levels (a type of blood fat) and improved physical function.
• Another recent trial in adults with pre-existing heart disease and obesity, but without type 2 diabetes, found adults receiving weekly 2.4mg semaglutide injections had a 20% lower risk of specific cardiovascular events, including having a non-fatal heart attack, a stroke or dying from cardiovascular disease, after three years follow-up.

Who is eligible for semaglutide?

• Australia’s regulator, the Therapeutic Goods Administration (TGA), has approved semaglutide, sold as Ozempic, for treating type 2 diabetes.
• The TGA has approved Wegovy to treat obesity but it’s not currently available in Australia.

What else do you need to do during Ozempic treatment?

• In addition to taking medication, people had brief lifestyle counselling sessions with dietitians or other health professionals every four weeks as a minimum in most trials.
• The aim of these trials was to show the effect of adding the medication on top of other lifestyle counselling.

A review of obesity medication trials found people reported they needed less cognitive behaviour training to help them stick with the reduced energy intake. This is one aspect where drug treatment may make adherence a little easier. Not feeling as hungry and having environmental food cues “switched off” may mean less support is required for goal-setting, self-monitoring food intake and avoiding things that trigger eating.

But what are the side effects?

• In on study these led to discontinuation of medication in 6% of people, but interestingly also in 3% of people taking placebos.
• More severe side-effects included gallbladder disease, acute pancreatitis, hypoglycaemia, acute kidney disease and injection site reactions.
• Here are some potential risks and benefits

  To reduce risk or severity of side-effects, medication doses are increased very slowly over months.

• Health, Meat and Livestock Australia, and Greater Charitable Foundation.
• She has consulted to SHINE Australia, Novo Nordisk, Quality Bakers, the Sax Institute, Dietitians Australia and the ABC.