Semaglutide, an FDA-approved treatment for diabetes and obesity, is making waves in the medical field. Let’s delve into some of the ongoing clinical trials exploring its potential in 2024. Here is the list of top 12 trials in 2024:
| Study Title | Sponsor |
|---|---|
| Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome | University of Colorado, Denver |
| Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease | Yale University |
| Semaglutide in Nonalcoholic Fatty Liver Disease | Zagazig University |
| Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3) | Vanderbilt University Medical Center |
| Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome | Peking University First Hospital |
| The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician) With Regards to Change in Weight and Intracranial Pressure | Rigmor Højland Jensen |
| Semaglutide and Vascular Regeneration | Canadian Medical and Surgical Knowledge Translation Research Group |
| Pharmacogenetics of Response to GLP1R Agonists | University of Maryland, Baltimore |
| Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity? | Psychiatric Centre Rigshospitalet |
| Semaglutide and Physical Activity for Obesity and Multimorbidity | Hvidovre University Hospital |
1. Feasibility of Semaglutide in Advanced Lung Disease
The first trial we’re looking at is titled “Feasibility of Semaglutide in Advanced Lung Disease”. This study, currently in the recruiting phase, aims to determine whether semaglutide is feasible and tolerable in patients with advanced lung disease. The trial seeks to answer two main questions:
- Can patients with advanced lung disease tolerate semaglutide therapy?
- Can semaglutide therapy be titrated to a target weight?
Participants will undergo pulmonary function, physical function, and body composition testing, as well as a blood draw before and after 12 weeks of semaglutide therapy. The primary outcome measure is the tolerability of the drug, specifically whether participants reach a target semaglutide dose of 1.0 mg/week or achieve target weight. The trial also aims to observe changes in body composition, lung function, physical function, and markers of adiposity and insulin resistance.
2. Semaglutide as Treatment in New-onset Idiopathic Intracranial Hypertension
The second trial, “The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician)” 2, is also currently recruiting. This study involves 50 patients with new-onset IIH who are randomly allocated to standard weight management (dietician counselling) or trial intervention consisting of subcutaneous injections with Semaglutide for 10 months, combined with a Very Low Calorie-Diet (max 800 kcal/day) in the initial 8 weeks following diagnosis.
The primary outcome measures are weight change (%) and change in lumbar opening pressure in cm cerebrospinal fluid measured by manometry, both observed over 8 weeks. The trial will also monitor these measures over 10 months, along with changes in the total score of Quality of Life (psychological, social, physical, environmental) assessed by the World Health Organization.
3. Semaglutide and Vascular Regeneration
The third trial, “Semaglutide and Vascular Regeneration” , is a prospective, randomized, 6-month long, open-label study of semaglutide. The study aims to understand how semaglutide exerts cardio-protective effects in people with type 2 diabetes and/or obesity. The main question it aims to answer is whether semaglutide treatment preserves or increases the number of vessel-repairing cells circulating in the blood. Participants will be allocated to receive either semaglutide or usual care for 6 months and provide a blood sample at the baseline visit and another blood sample at the 6-month visit. The primary outcome measure is the changes in the mean frequency (%) of circulating ALDHhiSSClow primitive progenitor cells in individuals treated with semaglutide versus usual care for 6 months.
4. Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?
The fourth trial, “Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?” , is a 26-week long, double-blinded randomized clinical trial. It aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI>30 kg/m2). Patients will be treated for 26 weeks with semaglutide subcutaneously (s.c.) once weekly or placebo. The medication will be provided as a supplement to standardised cognitive behavioural therapy. A subgroup of the patients will have two brain scans (Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI)) conducted in one scan session at week 0 and 26. The primary endpoint is the percentage-point reduction in the total number of heavy drinking days, defined as days with an excess intake of 48/60 grams of alcohol per day (women and men, respectively) from baseline to follow-up after 26 weeks of treatment, measured by the timeline followback (TLFB) method.
5. Anti-obesity Pharmacotherapy and Inflammation
The fifth trial, “Anti-obesity Pharmacotherapy and Inflammation” , is currently recruiting and evaluates the relationship between weight loss, circulating inflammatory markers, and lipids from 24 patients before and after 6 months of pharmacotherapy as a standard of care for anti-obesity treatment. The primary outcome measures include weight loss percentage, changes in the number of MDSC in blood, and changes in the concentration of each type of lipids: LDL-Cholesterol, triglycerides, and free fatty acids. The trial also aims to observe changes in systemic inflammation measured by C-reactive protein levels and adipokines levels in circulation.
6. Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
The sixth trial, “Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease” , is also currently recruiting. This study aims to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of β-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD. The primary outcome measures are the change in Oral Disposition Index (oDI) and Protein Density Fat Fraction (PDFF) from baseline to 6 months on treatment.
7. Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)
The seventh trial, “Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)” , is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight. This study will test the central hypothesis that semaglutide will improve asthma control and reduce airway inflammation due to direct effects on the respiratory tract in adult asthma associated with obesity. The primary outcome measures are the efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity, and the impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity.
8. Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM
The eighth trial, “Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM” , aims to conduct a community intervention study that will validate a screening approach to identify patients at risk for advanced NAFLD in the obese or T2DM population, and test whether semaglutide treatment is effective for the management of significant fibrosis due to NAFLD in high-risk patients. The primary outcome measures are the change in fibrosis due to Nonalcoholic fatty liver disease (NAFLD), as measured by change in FAST Score, which combines FibroScan results with aspartate aminotransferase (AST), and the change in liver stiffness, as measured by change in Vibration-Controlled Transient Elastography.
9. Semaglutide in Nonalcoholic Fatty Liver Disease
The ninth trial, “Semaglutide in Nonalcoholic Fatty Liver Disease” , is currently recruiting and is sponsored by Zagazig University. The trial is being conducted at Zagazig University, Zagazig, Sharkia, Egypt. The goal of this clinical trial is to test the therapeutic effect of Semaglutide in NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus. The main question it aims to answer is whether the use of Semaglutide (oral or subcutaneous form) is effective in improving NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus. The primary outcome measures are NAFLD regression and fibrosis regression.
10. A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss
The tenth trial, “A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss” , is currently recruiting. This study is researching experimental drugs called trevogrumab and garetosmab (called “study drugs”) in combination with another drug, semaglutide (Wegovy®). The aim of the study is to see how safe and tolerable the study drug is in healthy participants and how safe and effective the study drug is when combined with Wegovy. The primary outcome measures are the incidence of treatment-emergent adverse events (TEAEs), severity of TEAEs, percent body weight change, and percent change in total fat mass.
11. Semaglutide Therapy for Alcohol Reduction – Tulsa
The eleventh trial, “Semaglutide Therapy for Alcohol Reduction – Tulsa” , is currently recruiting and is sponsored by the Oklahoma State University Center for Health Sciences. The trial is being conducted at the OSU Biomedical Imaging Center, Tulsa, Oklahoma, United States. The purpose of this research study is to determine if semaglutide, when compared to placebo, is safe and may reduce alcohol drinking in individuals who endorse symptoms consistent with alcohol use disorder.
The study aims to answer several research questions, including:
- What side effects may happen from taking the study drug?
- How much study drug is in the blood at different times?
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)?
The primary outcome measures include:
- Change in alcohol drinking: The difference in the number of standard alcoholic drinks consumed per week (Drinks Per Week, DPW) from baseline (Week 1) to post-medication (Week 13).
- Change in heavy drinking days: The difference in the number of heavy drinking days as reported in Alcohol TLFB from baseline (Week 1) to post-medication (Week 13).
- Change in drinks per drinking days: The difference in the number of drinks per drinking days as reported in Alcohol TLFB from baseline (Week 1) to post-medication (Week 13).
- Safety and tolerability of semaglutide in individuals with alcohol use disorder (AUD): The number and grade of adverse events in individuals with AUD who receive semaglutide or placebo from baseline (Week 1) to post-medication (Week 13).
The study also aims to observe changes in food choices in a virtual reality buffet-like laboratory, changes in blood phosphatidylethanol (PEth) levels as a biomarker of alcohol use, and changes in brain activity in response to alcohol cues during fMRI cue reactivity task, during an fMRI interoceptive attention task, and during an alcohol-related Go/No-Go fNIRS task.
12. Semaglutide and Physical Activity for Obesity and Multimorbidity
The twelfth trial, “Semaglutide and Physical Activity for Obesity and Multimorbidity” , is currently recruiting. This observational study aims to explore and describe changes in cardiometabolic health, physical activity, physical capacity, and wellbeing during interdisciplinary Semaglutide-based weight loss treatment in patients with severe obesity and multimorbidity. The study is explorative and therefore does not include hypothesis testing.
The primary outcome measure is habitual physical activity. SENS Motion accelerometry will be used to measure habitual physical activity, defined as time spent non-sedentary and not lying down. Data will be presented as mean change in hours/day spent physically active between baseline, four months, and follow-up.
The study also aims to observe changes in health-related quality of life: physical, 10-years cardiovascular risk (previous cardiovascular disease), 10-years cardiovascular risk (type 2 diabetes), and 10-years cardiovascular risk (apparently healthy).
