Semaglutide news and clinical trials

McGill University Health Centre registered a 24-week clinical trial enrolling 40 adults to evaluate how semaglutide affects body composition in people with type 1 diabetes and overweight or obesity compared to a placebo.

LMC Diabetes & Endocrinology Ltd. registered an observational study to evaluate the effectiveness of switching from injectable semaglutide to tirzepatide in 650 adults living with type 2 diabetes and obesity.

A randomized clinical trial involving 72 participants found that semaglutide treatment in patients with major depressive disorder resulted in increased exploitation and directed exploration behaviors. The study highlights the role of metabolic mechanisms in decision-making processes for MDD.

A multicenter phase 4 study found that weekly 0.5 or 1 mg subcutaneous semaglutide injections significantly improved HbA1c, fasting blood glucose, and weight in 104 Chilean patients with type 2 diabetes.

Massachusetts General Hospital registered a pilot study enrolling 40 adults to determine if semaglutide affects brain reactivity to cannabis-related cues and reduces the frequency of cannabis use in individuals with cannabis use disorder.

Novo Nordisk A/S registered an observational study of 10000 adults in Australia to generate real-world evidence on the use of semaglutide among people receiving care through a digital weight loss service.

New meta-analysis in Frontiers in endocrinology: CagriSema versus Semaglutide 2.4 mg monotherapy for weight management in adults with overweight or obesity, with or without type 2 diabetes: a systematic review, meta-analysis, and trial sequential analysis.

Morten Hostrup registered a trial to study the long-term effects of semaglutide on body composition, running performance, and hormonal markers in 41 well-trained athletes. This research aims to address the unknown impact of semaglutide on physical performance in lean, fit runners.

Morten Hostrup registered a trial to investigate the short-term effects of semaglutide on body composition and exercise performance in 41 well-trained male and female runners. The study aims to determine how the drug influences muscle mass and function during caloric restriction.

Sponsor Signe Torekov registered a phase 4 randomized controlled trial to investigate an enhanced family care intervention combined with semaglutide or placebo for intergenerational obesity, aiming to enroll 400 participants.

Carolina Infusion, LLC initiated a class II recall of various semaglutide and semaglutide/cyanocobalamin injectables. The firm cited a lack of assurance of sterility related to the use of bacteriostatic water and processing equipment.

Universitaire Ziekenhuizen KU Leuven registered a Phase 4 study to determine how semaglutide affects eating behavior and weight regulation in 96 participants with obesity or overweight. Researchers are investigating which patients respond best to semaglutide treatment over 6 months.

Sheba Medical Center completed a Phase 2 trial of an algorithmic polytherapy regimen involving semaglutide and other agents in 31 healthy aging participants. The study characterized individual responses to these interventions over approximately 8 weeks.

Amgen registered a Phase 3 trial to compare the efficacy and safety of once-monthly maridebart cafraglutide against once-weekly semaglutide in 1300 participants with type 2 diabetes. The study aims to evaluate if the monthly treatment is non-inferior to semaglutide for glycemic control.

Kristin Clemens registered a trial to test a weight loss program combining semaglutide and virtual coaching for 880 patients with obesity and advanced kidney disease. The study aims to help patients achieve a healthier body weight to facilitate potential kidney transplantation.

Istanbul Saglik Bilimleri University registered a prospective descriptive study of 42 participants to assess the relationship between GLP-1 receptor agonist use and sarcopenia in non-diabetic individuals with obesity. Researchers will evaluate body composition changes over 3 months.

The General Committee of Teaching Hospitals and Institutes in Egypt registered a Phase 4 randomized, placebo-controlled trial (NCT07859137) enrolling 100 patients with a BMI of 60 kg/m² or higher. The study will evaluate the safety and feasibility of using semaglutide before bariatric surgery.

The General Committee of Teaching Hospitals and Institutes in Egypt registered a Phase 4 trial (NCT07859150) enrolling 104 participants to study semaglutide 2.4 mg for recurrent weight gain after bariatric surgery. It is a randomized, double-blind, placebo-controlled study.

The General Committee of Teaching Hospitals and Institutes in Egypt registered a trial to evaluate semaglutide for recurrent weight gain in 100 patients after sleeve gastrectomy surgery. The study compares the drug to a placebo before and after conversion to Roux-en-Y gastric bypass.

The General Committee of Teaching Hospitals and Institutes in Egypt registered a Phase 4 randomized trial with 100 participants to compare tapered versus abrupt discontinuation of semaglutide. The study investigates strategies for stopping treatment after weight regain following bariatric surgery.

The General Committee of Teaching Hospitals and Institutes in Egypt registered a Phase 4 trial (NCT07859189) enrolling 100 participants. It compares immediate semaglutide treatment versus criterion-triggered treatment for patients with suboptimal weight loss 1 year after bariatric surgery.

Novo Nordisk A/S registered a phase 1 clinical trial enrolling 60 participants to determine which dose of zenagamtide can be substituted for a maintenance dose of semaglutide in adults with overweight or obesity.

Boehringer Ingelheim registered a phase 3 trial to evaluate initiation strategies for survodutide, including new use or switching from semaglutide or tirzepatide, in 350 adults with obesity but no diabetes. The study aims to determine if survodutide helps these participants lose weight.

Peking University People's Hospital registered a trial to evaluate if adding finerenone to semaglutide further reduces the urinary albumin-to-creatinine ratio in 266 non-diabetic adults with obesity and chronic kidney disease. The treatment period lasts 24 weeks.

Novo Nordisk registered an observational study to assess patient and physician experiences with semaglutide across six emerging markets. The study enrolled 1260 participants.

Zomagen Biosciences posted results for a phase 2a study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of VTX3232, administered alone or with semaglutide, in 175 participants with obesity.

Pfizer registered a Phase 3 trial to evaluate the safety and effectiveness of switching to monthly berobenatide in 660 adults who have already lost weight while taking weekly semaglutide or tirzepatide. The study excludes people with diabetes and spans about 11 months.

Novo Nordisk registered a phase 1 trial to investigate the effect of high dose semaglutide on gastric emptying in 60 participants with obesity.

University Hospital, Angers registered a phase 3 trial to assess the efficacy of semaglutide in 50 children aged 12 to 17 years with hypothalamic obesity secondary to craniopharyngioma.

Nordic Biotic Sp. z o.o. registered a trial of 102 participants to evaluate if a four-strain probiotic formulation reduces gastrointestinal adverse events in adults with obesity treated with semaglutide. The study tracked participants over a 12-week treatment and dose-escalation period.

LMC Diabetes & Endocrinology Ltd. has completed a retrospective longitudinal analysis of 3392 patients to assess the real-world effectiveness of semaglutide on cardio-kidney-metabolic outcomes. The study evaluated HbA1c changes over 3 years in adults with Type 2 diabetes.

Shanghai JMT-Bio Inc. registered a phase 1 trial of 90 participants to evaluate the safety, tolerability, and pharmacokinetics of JMT206 injection, both alone and combined with semaglutide, in obese participants.

The Second Affiliated Hospital of Soochow University registered a completed phase 2 trial comparing the effects of BGM0504 injection versus semaglutide injection on insulin sensitivity and body weight in 60 obese or overweight participants.

New systematic review in Frontiers in pharmacology: Risk of neoplasms with semaglutide in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

Eli Lilly and Company posted results for a phase 3 study comparing the efficacy and safety of orforglipron to oral semaglutide in 1698 participants with type 2 diabetes inadequately controlled with metformin.

A study analyzing the ADJUST-T1D extension trial evaluated glycaemic changes after semaglutide discontinuation in adults with Type 1 diabetes and obesity. Discontinuation was associated with a greater decline in time in range and increased glycaemic variability compared with placebo.

New randomized trial in Journal of diabetes and its complications: Effects of semaglutide and empagliflozin on markers of endothelial function in persons with type 2 diabetes: A post hoc analysis of a randomized clinical trial.

A systematic review and meta-analysis of 10 studies including 41 381 participants found that tirzepatide was associated with greater weight reduction and better HbA1c control than semaglutide. Tirzepatide was also associated with a higher risk of serious adverse events.

A meta-analysis of 1776 participants found that weight regain is rapid after discontinuing semaglutide or tirzepatide, with an average regain of 1.04 kg/month. Patients were projected to return to their baseline weight within 15.00 months.

New systematic review in International journal of obesity (2005): Effects of subcutaneous semaglutide on weight loss and inflammatory markers in adults with overweight or obesity without diabetes: a systematic review and meta-analysis.

Researchers conducted a systematic review to determine if specific days of the week are better for semaglutide or tirzepatide administration. The study found no comparative data on day-of-week effects, concluding that flexible dosing schedules are best for adherence.

Apollo Care, LLC initiated a class II recall of multiple semaglutide and semaglutide/glycine injectable products. The recall follows the identification of particulate matter, specifically nylon/polyamide and silk/proteinaceous-type material, in the vials.

A prespecified analysis of the SELECT trial found that semaglutide significantly reduced high-sensitivity C-reactive protein (hsCRP) levels in patients with cardiovascular disease and obesity. Lower inflammation levels were associated with a reduced risk of major adverse cardiovascular events.

A meta-analysis of 8 observational cohort studies involving 5,916,559 participants found a significant association between semaglutide use and the risk of nonarteritic anterior ischemic optic neuropathy (NAION), particularly in individuals with diabetes.

A randomized trial in Japan evaluated adding luseogliflozin to semaglutide in patients with MASH and type 2 diabetes. While combination therapy did not significantly improve histological endpoints compared to monotherapy, it did improve body weight, liver stiffness, and glycemic control.

Researchers meta-analyzed 32 randomized controlled trials with 47,332 participants assessing blood pressure adverse events. Tirzepatide reduced hypertension risk but increased hypotension risk, while semaglutide showed a neutral safety profile regarding blood pressure.

A systematic review and meta-analysis of data through January 2026 found no statistically significant increase in the risk of depression, anxiety, or suicidal ideation among patients receiving semaglutide compared with comparator groups.

A phase 3b trial of 242 Chinese adults with overweight or obesity found that semaglutide 2·4 mg achieved greater bodyweight reduction compared to placebo over 44 weeks. The study noted that 80·5% of participants on semaglutide achieved at least 5% bodyweight reduction.

New randomized trial in The lancet. Diabetes & endocrinology: Effect of semaglutide on kidney outcomes in the SELECT, FLOW, and SOUL trials: a prespecified pooled analysis.

New systematic review in Journal of endocrinological investigation: Analysis of the efficacy and safety of liraglutide, semaglutide, and tirzepatide for the treatment of overweight and obesity: a systematic review and network meta-analysis.

New meta-analysis in Medicine: Effectiveness & safety of semaglutide in weight reduction in obese nondiabetic patients: A systematic review and meta-analysis.

The FDA announced the availability of additional revised draft product-specific guidances. These documents provide recommendations for industry on designing bioequivalence studies to support abbreviated new drug applications.

New randomized trial in The American journal of psychiatry: Oral Semaglutide for Alcohol Use Disorder: A Randomized Clinical Trial.

New phase 2 trial in HIV medicine: Semaglutide improves MASLD and MASH in people with HIV: The SLIM LIVER study.

A phase 3b study of 573 participants found that once-weekly semaglutide 2.0 mg added to reduced insulin glargine provided superior reductions in HbA1c, body weight, and daily insulin dose compared to dose-titrated insulin glargine alone. It also reduced the risk of severe hypoglycaemia.

A meta-analysis of placebo-controlled trials found that semaglutide significantly reduced liver enzymes and more than doubled the likelihood of NASH resolution without fibrosis progression in adults with NAFLD or NASH (RR = 2.14). Gastrointestinal adverse events occurred more frequently.

Researchers launched a Phase 3 clinical trial to test if adding semaglutide and dapagliflozin to insulin therapy improves outcomes in overweight adults with Type 1 Diabetes. The study aims to determine the efficacy and safety of this triple therapy approach compared to standard insulin care.

A phase 2 clinical trial involving 698 participants evaluated the safety and efficacy of combining zalfermin with semaglutide for treating fibrosis in patients with metabolic dysfunction-associated steatohepatitis. The trial concluded after assessing various dosage combinations over 52 weeks.

A subpopulation analysis of the SURMOUNT-5 trial found that tirzepatide led to greater weight loss (-20.1%) than semaglutide (-12.9%) in 383 participants with obesity disease after 72 weeks of treatment.

A randomized Phase III study in India involving 270 patients demonstrated that a synthetic semaglutide injection is non-inferior to Wegovy for weight management. At 24 weeks, both groups showed comparable weight loss results, with -13.8% for the test group and -14.1% for the reference group.

New systematic review in Obesity (Silver Spring, Md.): Wernicke's Encephalopathy Following Semaglutide Treatment for Obesity: A Systematic PRISMA Review of Case-Based Evidence.

Researchers conducted a Phase 3b trial intensifying insulin icodec treatment with semaglutide in adults with type 2 diabetes. Participants saw mean HbA1c decrease from 7.88% to 6.66% and body weight decrease by 3.85 kg from baseline to week 52.

A phase 2b trial found that bofanglutide, administered weekly or biweekly, effectively reduced HbA1c levels in 272 Chinese patients with type 2 diabetes. The study compared bofanglutide against semaglutide 1 mg QW over 24 weeks.

The FDA is extending the comment period for a notice concerning the 503B Bulks List of drug substances. This follows the agency's proposal not to include semaglutide, tirzepatide, or liraglutide on the list of bulk drug substances allowed for use in compounding.

The FDA announced it is proposing not to include semaglutide, tirzepatide, and liraglutide on the list of bulk drug substances for which there is a clinical need for outsourcing facilities to use in compounding. The agency is currently evaluating substances nominated for this list.

The FDA issued a notice determining that OZEMPIC solution, 2 milligrams per 1.5 milliliters, was not withdrawn from sale for reasons of safety or effectiveness. This decision allows the agency to continue approving abbreviated new drug applications for this product.

Payless Compounders, LLC initiated a voluntary recall of 91 vials of Semaglutide-Glycine-Cyanocobalamin injection. The recall is due to a lack of assurance of sterility.

Harbin Jixianglong Biotech Co., Ltd. initiated a voluntary recall of Semaglutide due to CGMP deviations. The firm failed to complete process validation and bacterial endotoxin method validation before distribution.

New Life Pharma LLC initiated a voluntary recall of 2 vials of Semaglutide injection. The reason for the recall is a lack of assurance of sterility.

The FDA announced the availability of additional draft and revised product-specific guidances. These documents provide recommendations for the design of bioequivalence studies to support abbreviated new drug applications.

The FDA issued a final debarment order prohibiting Jeremy Spencer Brown from importing or offering for import any drug into the United States for 5 years. This action follows a felony conviction for introducing unapproved drugs into interstate commerce.

Novo Nordisk Inc. initiated a voluntary recall of Wegovy semaglutide injection. The action was taken because hair was found in a prefilled syringe, indicating the presence of particulate matter.

The FDA announced the availability of new and revised draft product-specific guidances. These guidances offer industry recommendations on the design of bioequivalence studies for abbreviated new drug applications.

ProRx LLC initiated a voluntary recall of 8,400 vials of Semaglutide injection due to a lack of assurance of sterility.