Ongoing Clinical Trials for Endocrine Disorders
This article provides an overview of 6 ongoing clinical trials investigating treatments for various endocrine disorders, including Type 2 Diabetes following bariatric surgery, Cushing’s syndrome, Cushing’s disease, and related hormonal imbalances. These studies are testing medications such as metformin, metyrapone, SGLT-2 inhibitors, SPI-62, and silibinin across multiple countries in Europe.
Clinical trial locations
- Bulgaria
- France
- Italy
- Study on the Effect of Metyrapone on Heart Health in Patients with Adrenal Tumors and Mild Cushing’s Syndrome
- Study on the Safety and Effectiveness of Metformin Hydrochloride, Dapagliflozin, and Canagliflozin in Elderly Patients with Type 2 Diabetes
- Study on the Effectiveness and Safety of Silibinin for Patients with Active Cushing’s Disease
- Romania
Study of Metformin Treatment to Maintain Type 2 Diabetes Remission in Patients After Bariatric Surgery
This study is investigating whether metformin can help maintain diabetes remission in patients who have achieved diabetes-free status following bariatric surgery. The research focuses on individuals who underwent gastric bypass or sleeve gastrectomy procedures between 12 to 36 months ago.
Main inclusion criteria: Participants must be adults aged 18 to 70 years who previously had Type 2 Diabetes and used at least one diabetes medication before surgery, or had an HbA1c level of 6.5% or higher. Currently, their HbA1c must be below 6.5%, and they must not have taken any diabetes medications in the past 3 months.
Main exclusion criteria: The study excludes individuals below age 18 or above 64, those with active diabetes without remission after surgery, pregnant women or those planning pregnancy, people with known allergies to metformin, severe kidney or liver disease, history of lactic acidosis, alcohol or substance abuse, and mental health conditions that could affect study participation.
Focus and goal: The trial aims to compare two groups over three years. One group receives metformin treatment with a maximum daily dose of 1700 mg taken orally, while the other follows standard care without metformin. The study monitors blood sugar levels, weight changes, quality of life, and changes in digestive system bacteria to determine if metformin can extend the diabetes-free period after weight loss surgery.
Investigational drug: Metformin is a commonly prescribed diabetes medication that helps control blood sugar by improving insulin response and reducing liver sugar production. In this trial, it is being studied specifically to help maintain diabetes remission achieved through bariatric surgery.
Study on the Effect of Metyrapone on Heart Health in Patients with Adrenal Tumors and Mild Cushing’s Syndrome
This trial examines the effects of metyrapone on blood pressure control in patients who have both adrenal incidentalomas and subclinical or mild Cushing’s syndrome. Adrenal incidentalomas are unexpected tumors found in the adrenal glands located above the kidneys.
Main inclusion criteria: Participants must be between 18 and 75 years old with one or two non-cancerous adrenal nodules visible on CT scan. They must have subclinical Cushing’s syndrome, characterized by specific cortisol levels after testing, and arterial hypertension with blood pressure at or above 140/90 mmHg or be currently taking blood pressure medication. Candidates must not be suitable for adrenalectomy surgery.
Main exclusion criteria: The study excludes patients who do not have the specified adrenal conditions and subclinical or mild Cushing’s syndrome, those outside the specified age range, and those not meeting the clinical trial group criteria.
Focus and goal: The study lasts approximately 12 months and aims to determine if adding metyrapone to standard blood pressure treatment can reduce the number or dose of blood pressure medications needed while maintaining healthy blood pressure levels. The medication is taken as a soft capsule.
Investigational drug: Metyrapone works by reducing the production of certain hormones that affect blood pressure. The trial evaluates whether this medication can improve blood pressure management in patients with adrenal tumors and hormonal imbalances.
Study on the Safety and Effectiveness of Metformin Hydrochloride, Dapagliflozin, and Canagliflozin in Elderly Patients with Type 2 Diabetes
This study focuses on comparing several SGLT-2 inhibitor medications in elderly patients with Type 2 Diabetes. The trial tests multiple medications including Xigduo, Vokanamet, Forxiga, Synjardy, Jardiance, and Invokana.
Main inclusion criteria: Participants must be 70 years or older with Type 2 Diabetes and established cardiovascular disease or reduced kidney function (eGFR less than 90 ml/min/1.73 m²). Their HbA1c must be higher than their personalized target value, and there must be a clinical reason to start SGLT-2 inhibitor therapy. Written informed consent is required.
Main exclusion criteria: The study excludes patients without Type 2 Diabetes, those outside the specified age range, people unable to achieve individualized HbA1c targets without severe hypoglycemia, and vulnerable populations requiring special protection.
Focus and goal: This open-label, multi-center trial lasting up to 36 months evaluates how well these medications help elderly patients reach personalized blood sugar goals without severe low blood sugar episodes. The study monitors blood sugar levels, body weight, blood pressure, kidney function, and safety outcomes including hospitalizations, infections, dehydration, bone fractures, and diabetic ketoacidosis.
Investigational drugs: The trial tests four SGLT-2 inhibitors: empagliflozin, dapagliflozin, canagliflozin, and ertugliflozin. These medications help lower blood sugar by enabling the kidneys to remove excess glucose from the bloodstream through urine. All are taken orally as film-coated tablets.
Study of SPI-62 for Treating ACTH-Dependent Cushing’s Syndrome in Patients with Cushing’s Disease or Ectopic ACTH/CRH Secretion
This trial investigates SPI-62, a medication designed to reduce cortisol effects in patients with ACTH-dependent Cushing’s Syndrome. This includes Cushing’s Disease, where the pituitary gland produces too much ACTH, and conditions where ACTH is produced outside the pituitary gland.
Main inclusion criteria: Participants must be 18 years or older with active and consistent cortisol excess confirmed by elevated urinary free cortisol levels in at least two 24-hour urine samples, non-suppressed morning serum cortisol after an overnight dexamethasone test, and abnormal late-night salivary cortisol levels. They must have documented ACTH-dependent Cushing’s syndrome and current evidence of related health issues such as high blood sugar, abnormal cholesterol, high blood pressure, or weakened bones.
Main exclusion criteria: The study excludes patients without Cushing’s Syndrome, those outside the specified age range, individuals unable to follow study procedures, pregnant or breastfeeding women, people currently in other clinical trials, those with recent or planned surgery, individuals with drug or alcohol abuse history, and those allergic to the study medication.
Focus and goal: This 12-week trial evaluates SPI-62, taken orally as a film-coated tablet, by measuring the urinary HSD-1 ratio at Week 6 as the primary assessment. The study also monitors adverse events, laboratory evaluations, and various health indicators, with potential long-term monitoring in an open-label extension phase.
Investigational drug: SPI-62 works by inhibiting the enzyme 11β-hydroxysteroid dehydrogenase type 1 (HSD-1), which plays a role in cortisol production. The trial aims to assess whether this medication can effectively manage ACTH-dependent Cushing’s syndrome by reducing cortisol effects.
Study on the Effectiveness and Safety of Silibinin for Patients with Active Cushing’s Disease
This study evaluates Silycus®, containing the active substance silibinin derived from milk thistle fruit, for patients with active Cushing’s disease. The condition involves the body producing too much cortisol, leading to various health complications.
Main inclusion criteria: Participants must be adults aged 18 years or older with active Cushing’s disease confirmed by medical guidelines and records. They must have elevated cortisol levels shown through 24-hour urine tests 1.5 times above normal, late-night saliva tests showing high cortisol in at least two tests, and blood tests after dexamethasone showing cortisol levels higher than 1.8 micrograms per deciliter. Participants should be on inadequate or poorly tolerated treatments, or if newly diagnosed, not be candidates for surgery or have surgery delayed beyond the study period.
Main exclusion criteria: The study excludes patients without Cushing’s disease, those outside the specified age range, individuals unwilling to follow study procedures, pregnant or breastfeeding women, those with other serious health conditions that might interfere with the study, people currently in other clinical trials, those with recent or planned surgery, individuals with drug or alcohol abuse history, and those unable to provide informed consent.
Focus and goal: The 12-week trial evaluates whether Silycus®, taken orally as granules in a sachet, can reduce or normalize excess cortisol levels. The study monitors changes in clinical signs and symptoms including body weight, blood pressure, and glucose control, while also assessing the medication’s safety.
Investigational drug: Silycus® contains silibinin and works by targeting specific pathways to help control cortisol secretion. The trial aims to determine if it can effectively lower cortisol levels and improve overall health in patients with Cushing’s disease.
Study of SPI-62 for Treating Cushing’s Syndrome in Patients with Benign Adrenal Tumors
This clinical trial studies SPI-62 for treating hypercortisolism related to benign adrenal tumors. When adrenal glands produce too much cortisol, it can cause high blood sugar, high blood pressure, and weakened bones.
Main inclusion criteria: Adult participants must have non-cancerous adrenal gland growths causing autonomous cortisol secretion, confirmed by medical tests. They must have documented treatment for, or ongoing issues with, high blood sugar, high blood pressure, high cholesterol, or reduced bone density due to excessive cortisol levels. Surgery should be discussed as a first treatment option, with study inclusion only for those who have failed or rejected available surgical or medical treatments.
Main exclusion criteria: The study excludes patients without hypercortisolism related to a benign adrenal tumor, those not experiencing complications from autonomous cortisol secretion, individuals not receiving standard care management, those outside the specified age range, people not part of the specified clinical trial groups, and those not in the selected vulnerable population.
Focus and goal: This trial lasting up to 78 weeks evaluates the benefits and risks of SPI-62 compared to placebo. Participants are monitored for changes in hypercortisolism symptoms including high blood sugar, cholesterol, and blood pressure, as well as long-term safety focusing on serious health issues.
Investigational drug: SPI-62 is taken orally as a film-coated tablet and works as a cortisol synthesis inhibitor by blocking specific enzymes involved in cortisol production, thereby reducing excessive cortisol levels caused by benign adrenal tumors.
Summary
These 6 ongoing clinical trials represent diverse approaches to managing endocrine disorders, particularly focusing on diabetes management after bariatric surgery and various forms of Cushing’s syndrome. The trials are concentrated in European countries, with Italy hosting three studies, while Romania and Bulgaria participate in trials testing the novel agent SPI-62 for Cushing’s syndrome. France contributes research on post-bariatric diabetes management.
Several medications are being investigated across these trials. Metformin appears in two studies examining different contexts: maintaining diabetes remission after surgery and as part of combination therapy in elderly diabetes patients. The SGLT-2 inhibitor class receives significant attention, with one comprehensive trial comparing multiple agents in elderly populations. Novel investigational drugs include SPI-62, an enzyme inhibitor targeting cortisol production tested in three separate trials for different manifestations of Cushing’s syndrome, and Silycus® (silibinin), a plant-derived compound being evaluated for Cushing’s disease.
The trials demonstrate a focus on vulnerable populations, including elderly patients with complex metabolic conditions and individuals with rare hormonal disorders. Study durations vary from 12 weeks to 3 years, reflecting different research objectives from initial safety and efficacy assessment to long-term metabolic outcomes. These studies aim to provide evidence for treatment options in conditions where current therapies may be inadequate, poorly tolerated, or unavailable due to surgical contraindications.