Semaglutide terms and researches guide

The phase III STEP clinical program has made significant strides in the field of obesity treatment, highlighting that a 2.4 mg semaglutide dosage offers clinically meaningful and lasting weight loss, surpassing results from other available obesity agents. The study underscores the positive impact of semaglutide for weight loss, not just in shedding pounds but also in enhancing the quality of life and health of individuals with obesity or overweight, with or without type 2 diabetes (T2D).

The utilization of semaglutide for weight loss has demonstrated promising outcomes, especially for patients with overweight or obesity. In a real-world clinical setting, the effects of semaglutide treatment have mirrored the impressive weight loss results seen in randomized clinical trials. This correlation strongly suggests the practical applicability and effectiveness of semaglutide in treating individuals struggling with weight issues.

In a comprehensive study involving 201 adolescents, most of whom were battling obesity, the effectiveness of semaglutide was put to the test. Out of all participants, an impressive 90% adhered to the treatment regimen until its completion. The treatment plan was distinctive, combining a once-weekly 2.4-mg dosage of semaglutide with targeted lifestyle interventions aimed at fostering healthier habits. Over the course of 68 weeks, the results were striking. Those in the semaglutide group witnessed a significant decrease in BMI, averaging a notable reduction of − 16.1%. This was in stark contrast to the placebo group, which only recorded a minimal change of 0.6%. The difference between the two groups was substantial, highlighting the efficacy of semaglutide in this context.

This landmark study, published in The Lancet, compares the efficacy and safety of semaglutide with liraglutide and a placebo for weight loss in individuals with obesity. Conducted as a double-blind, randomized phase II trial, it involved 957 adults across seven countries, without diabetes and with a BMI of 30 kg/m² or higher. The participants were divided into groups receiving semaglutide, liraglutide, or a placebo, with subcutaneous injections administered daily for 52 weeks.

The research findings demonstrated that all treatment groups experienced greater weight reduction than the placebo group. Notably, semaglutide doses above 0.1 mg resulted in significantly more weight loss after 52 weeks compared to the liraglutide group. The weight loss was dose-dependent, with 19-65% of participants in the semaglutide groups losing 10% or more of their body weight, contrasted with 34% for liraglutide and 10% for the placebo group. The estimated mean weight loss ranged from −2.3% in the placebo group to −13.8% in the highest semaglutide dose group.

While adverse events were more frequent and dose-dependent among semaglutide participants, they were primarily gastrointestinal in nature, such as nausea, diarrhea, and vomiting. Importantly, there were no severe hypoglycemic episodes in either treatment group. This study underscores the potential of semaglutide in promoting substantial weight reduction in individuals with obesity, although the increase in adverse events with higher doses warrants careful consideration.

This landmark study, published in The Lancet, compares the efficacy and safety of semaglutide with liraglutide and a placebo for weight loss in individuals with obesity. Conducted as a double-blind, randomized phase II trial, it involved 957 adults across seven countries, without diabetes and with a BMI of 30 kg/m² or higher. The participants were divided into groups receiving semaglutide, liraglutide, or a placebo, with subcutaneous injections administered daily for 52 weeks.

The research findings demonstrated that all treatment groups experienced greater weight reduction than the placebo group. Notably, semaglutide doses above 0.1 mg resulted in significantly more weight loss after 52 weeks compared to the liraglutide group. The weight loss was dose-dependent, with 19-65% of participants in the semaglutide groups losing 10% or more of their body weight, contrasted with 34% for liraglutide and 10% for the placebo group. The estimated mean weight loss ranged from −2.3% in the placebo group to −13.8% in the highest semaglutide dose group.

While adverse events were more frequent and dose-dependent among semaglutide participants, they were primarily gastrointestinal in nature, such as nausea, diarrhea, and vomiting. Importantly, there were no severe hypoglycemic episodes in either treatment group. This study underscores the potential of semaglutide in promoting substantial weight reduction in individuals with obesity, although the increase in adverse events with higher doses warrants careful consideration.

The STEP 6 trial, published in 2022, explores the efficacy of semaglutide for weight management in East Asian adults with obesity, with or without type 2 diabetes. This phase 3a trial, involving 401 participants across Japan and South Korea, compares weekly semaglutide doses of 2.4 mg and 1.7 mg against placebo over 68 weeks. All participants received lifestyle recommendations alongside the treatment.

The study reports significant weight loss in both semaglutide groups compared to placebo. The 2.4 mg semaglutide group achieved an average weight loss of 13.2%, and the 1.7 mg group saw a 9.6% reduction, against a mere 2.1% in the placebo group. Notably, 83% of participants in the 2.4 mg group and 72% in the 1.7 mg group achieved at least a 5% reduction in baseline bodyweight. Additionally, the study measured a substantial decrease in abdominal visceral fat area, particularly in the 2.4 mg semaglutide group, where it was reduced by 40.0%.

The trial reported a higher incidence of mild to moderate gastrointestinal adverse events in the semaglutide groups. However, these did not significantly impact the continuation of the treatment. The findings from the STEP 6 trial demonstrate that semaglutide, particularly at a 2.4 mg dose, can be an effective and promising option for weight management in East Asian populations with obesity, extending its potential benefits beyond glucose regulation in type 2 diabetes.

This systematic review, focusing on the potential benefits of GLP-1 receptor agonists (GLP1-RAs) in managing Prader-Willi syndrome (PWS), evaluates their efficacy in weight, glycaemic, and appetite control for PWS patients. PWS is a complex genetic condition characterized by hyperphagia and obesity, traditionally managed through diet, supervision, and behavioral modifications, often creating stress for patients and caregivers.

The review encompasses ten studies, analyzing the effects of GLP1-RAs on 23 PWS patients aged 13 to 37 years. These patients, many of whom had type 2 diabetes mellitus (T2DM), were treated with either exenatide or liraglutide for periods ranging from 14 weeks to 4 years. The review found that 16 (70%) of these patients had T2DM. Notably, ten patients experienced significant improvements in body mass index (BMI), with reductions ranging from 1.5 to 16.0 kg/m². Additionally, 19 out of 23 cases showed improvement in HbA1c levels, varying between 0.3% and 7.5%. The studies also reported increased satiety and reduced appetite, with no serious side effects.

The findings suggest that GLP1-RAs are safe for PWS patients and could offer benefits in managing weight, glycemic control, and appetite. However, the review highlights the significant gap in well-designed studies in this area. This limitation restricts the current recommendation of GLP1-RA use in PWS patients. Overall, while the results are promising, more robust research is needed to fully understand and validate the efficacy of GLP1-RAs in the treatment of PWS.

This clinical trial aims to evaluate the effectiveness of Semaglutide versus Metformin in achieving weight loss in obese women with Polycystic Ovary Syndrome (PCOS) over 28 weeks. PCOS, a common metabolic disorder, is often accompanied by obesity, increasing the risk for type 2 diabetes and cardiovascular diseases. Traditional management of PCOS-related obesity includes dietary restrictions and lifestyle changes, which can be challenging to maintain. Metformin, a well-established treatment for PCOS, improves insulin sensitivity and has shown varied effects on body weight. In contrast, Semaglutide, a newer GLP-1 receptor agonist, has demonstrated significant weight loss in patients with type 2 diabetes and is known for its potential in weight management.

In this trial, participants are randomly assigned to receive either Semaglutide or Metformin. The Semaglutide group receives weekly subcutaneous injections with a dose gradually increasing to 2.4 mg a week, while the Metformin group receives an oral dose starting from 500 mg/day, increasing to a maximum of 1500 mg/day. The trial evaluates weight reduction, hormonal and metabolic changes, quality of life, and cardiovascular risk factors.

The hypothesis is that Semaglutide treatment will lead to more substantial weight loss compared to Metformin, along with improvements in metabolic parameters and quality of life in obese women with PCOS. This trial holds significance as it compares two different pharmacological approaches to manage a crucial aspect of PCOS – obesity and its related complications.

The STEP 2 trial, published in March 2021, evaluates the efficacy and safety of once-weekly subcutaneous semaglutide 2.4 mg compared to semaglutide 1.0 mg (approved dose for diabetes treatment) and placebo in weight management for adults with overweight or obesity and type 2 diabetes. The study, a double-blind, double-dummy, phase 3 trial, involved 1210 patients from various global locations. Participants were randomly assigned to receive either semaglutide 2.4 mg, semaglutide 1.0 mg, or a placebo, alongside a lifestyle intervention for 68 weeks.

The trial’s findings show that semaglutide 2.4 mg led to a significant reduction in body weight (mean change of -9.6%) compared to placebo (-3.4%). The treatment difference between semaglutide 2.4 mg and placebo was -6.2 percentage points, with a higher proportion of patients in the semaglutide group achieving weight reductions of at least 5% compared to placebo. This outcome was observed in 68.8% of patients on semaglutide 2.4 mg versus 28.5% on placebo.

Adverse events were more common in the semaglutide groups, with gastrointestinal issues being the most frequent, but these were mostly mild to moderate in severity. This study establishes the superiority and clinical significance of semaglutide 2.4 mg in reducing body weight compared to placebo in adults with overweight or obesity and type 2 diabetes, marking it as a promising treatment option for this patient population.

This clinical trial investigated the effectiveness of once-weekly 2.4 mg subcutaneous semaglutide injections as an adjunct to lifestyle intervention in adults with obesity. The double-blind study enrolled 1961 participants without diabetes, randomly assigning them to either the semaglutide or placebo group. The primary goal was to evaluate changes in body weight and the achievement of at least a 5% weight reduction over 68 weeks.

The results were significant, with the semaglutide group experiencing a mean weight reduction of 14.9% compared to 2.4% in the placebo group. This translates to an average weight loss of 15.3 kg with semaglutide, versus 2.6 kg with placebo. Furthermore, a higher proportion of participants in the semaglutide group achieved weight reductions of 5%, 10%, and 15% or more. Semaglutide also led to improvements in cardiometabolic risk factors and physical functioning. The most common adverse events reported were gastrointestinal in nature, such as nausea and diarrhea, and were typically transient and mild to moderate in severity. The trial concluded that semaglutide, combined with lifestyle intervention, is effective for significant and sustained weight reduction in adults with overweight or obesity.

This research discusses the rationale and design of the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity) trial. This randomized, double-blind, placebo-controlled trial aims to compare semaglutide with placebo in preventing major adverse cardiovascular events in patients with established cardiovascular disease (CVD) and overweight or obesity. The primary objective is to prove the superiority of semaglutide in reducing the incidence of major adverse cardiovascular events.

Semaglutide, known for its potential in weight loss and preliminary cardiovascular data, is positioned as a possible cardioprotective agent in high-risk individuals with overweight or obesity but without diabetes. The SELECT trial is significant as it is the first cardiovascular outcomes trial evaluating an antiobesity medication's effectiveness in reducing major adverse cardiovascular events in this specific population. If successful, the SELECT study could be a groundbreaking advancement in new approaches to CVD risk reduction while targeting obesity.

The trial underscores the growing recognition of the link between obesity, diabetes, and cardiovascular disease. A positive outcome in the SELECT study could lead to semaglutide becoming a standard-of-care treatment for obesity and associated CVD risk, potentially revolutionizing the approach to managing cardiovascular risk in patients with obesity but without diabetes. This study marks a significant step in addressing the complex relationship between obesity, metabolic health, and cardiovascular outcomes.

This study evaluated the effectiveness of a once-weekly 2.4-mg dose of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, in treating obesity in adolescents. In this double-blind, parallel-group, randomized, placebo-controlled trial, adolescents aged 12 to under 18 years with obesity (BMI in the 95th percentile or higher) or overweight (BMI in the 85th percentile or higher) and at least one weight-related coexisting condition were enrolled. They were randomly assigned to receive either semaglutide or placebo for 68 weeks, combined with a lifestyle intervention.

The trial involved 201 participants, with 180 (90%) completing the treatment. The results showed a significant mean reduction in BMI of -16.1% with semaglutide compared to 0.6% with placebo, marking an estimated difference of -16.7 percentage points. Additionally, 73% of the semaglutide group achieved a weight loss of 5% or more, compared to 18% in the placebo group. Improvements were also observed in cardiometabolic risk factors, including waist circumference, levels of glycated hemoglobin, lipids (except high-density lipoprotein cholesterol), and alanine aminotransferase. However, the incidence of gastrointestinal adverse events was higher with semaglutide (62%) compared to placebo (42%). Cholelithiasis was reported in five participants (4%) in the semaglutide group, with no cases in the placebo group. Serious adverse events occurred in 11% of the semaglutide group and 9% of the placebo group

This study investigates the association between semaglutide use and depression, reporting two cases where semaglutide use was linked to the development or exacerbation of depressive symptoms. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), is approved for glucose control in type 2 diabetes mellitus and weight loss. While known for its efficacy in managing these conditions, no psychiatric adverse effects have been previously reported with semaglutide.

The first case involves a middle-aged man with no history of depression who developed depressive symptoms about one month after starting semaglutide. His symptoms improved upon discontinuing the medication. The second case is of a middle-aged woman with a history of recurrent depressive disorder. Her depressive symptoms also recurred about one month following the initiation of semaglutide treatment and improved after its discontinuation. Both cases suggest a potential link between semaglutide therapy and the onset of depressive symptoms.

These observations highlight the need for clinicians to be aware of possible psychiatric adverse effects, including depression, when prescribing semaglutide. While semaglutide is effective for blood glucose control and weight loss, these cases underscore the importance of monitoring patients' mental health during treatment, especially those with a history of depression or other psychiatric conditions. Further research is needed to understand the mechanisms behind these observations and to establish a clearer connection between semaglutide use and psychiatric effects.

The study focuses on the efficacy and tolerability of semaglutide in managing antipsychotic-associated weight gain (AAWG) among individuals with severe mental illness. This case series involved a retrospective chart review of patients treated with semaglutide in the Metabolic Clinic at the Center for Addiction and Mental Health between 2019 and 2021. Patients who did not respond to metformin were initiated on semaglutide, with the primary outcome measure being a change in weight at 3, 6, and 12 months.

The analysis included twelve patients, with an average age of 36 years. Significant weight loss was observed at all intervals: 4.56 kg at 3 months, 5.16 kg at 6 months, and 8.67 kg at 12 months post-initiation of semaglutide. This weight loss was associated with well-tolerated side effects. The study provides initial evidence that semaglutide may be effective in reducing AAWG in patients not responding to metformin. This case series highlights the potential of semaglutide as an adjunctive pharmacological intervention in AAWG treatment. However, the authors acknowledge the limitations of their study, including its small sample size and retrospective nature, and call for randomized controlled trials to further validate these findings.