预约演示
更新于：2026-01-31
Semaglutide (Qilu Pharmaceutical)
司美格鲁肽（齐鲁制药）
更新于：2026-01-31
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基本信息
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3
项与 司美格鲁肽（齐鲁制药） 相关的临床试验NCT05950516
Efficacy and Safety of Semaglutide Injection (QLG2065) vs. Ozempic? as add-on to Metformin in Type 2 Diabetics.
CTR20230548
司美格鲁肽注射液人体药代动力学研究
CTR20255180
一项多中心、随机、开放、阳性药平行对照的评价司美格鲁肽注射液（QLM2019） 和诺和盈®治疗成人肥胖的有效性和安全性的Ⅲ期临床试验
100 项与 司美格鲁肽（齐鲁制药） 相关的临床结果
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100 项与 司美格鲁肽（齐鲁制药） 相关的转化医学
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100 项与 司美格鲁肽（齐鲁制药） 相关的专利（医药）
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24
项与 司美格鲁肽（齐鲁制药） 相关的文献（医药）2025-11-01JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
2025 ACC Scientific Statement on the Management of Obesity in Adults With Heart Failure
Review
作者: Vest, Amanda R. ; Januzzi, James L. ; Harrington, Josephine ; McMurray, John J.V. ; Kittleson, Michelle M. ; Benjamin, Emelia J. ; Blumer, Vanessa
Obesity confers increased risks of HF, coronary artery disease, and stroke, and weight loss can reduce cardiovascular disease risk. Given emerging evidence of the benefits of semaglutide and tirzepatide in individuals with HFpEF and obesity in concert with healthy behavioral interventions, clinicians should be aware of optimal diagnosis, risk assessment, and management of obesity in individuals with HF. Despite the early promise of anti-obesity medications in HFpEF, challenges remain, including whether BMI is the optimal metric to identify obesity and subsequent benefit from anti-obesity medications; the safety profile of anti-obesity medications for individuals with HF, particularly HFrEF; and whether the benefits of anti-obesity medications are attributed mainly to the magnitude of weight loss or due to other mechanisms of action. Motivated by this emerging evidence and ongoing challenges, this scientific statement: 1) reviews the diagnosis, evaluation, and risk assessment of obesity in HF; 2) describes HF-specific management strategies from lifestyle intervention to medications to surgery; and 3) addresses evidence gaps and future directions in obesity-related HF. With accurate evaluation of obesity as well as administration and monitoring of safe and effective interventions, clinicians may improve quality of life and functional capacity and potentially reduce HF events in individuals living with HF and obesity.
2025-08-01CLINICAL NUTRITION
Psychiatric and psychological adverse effects associated with dulaglutide, semaglutide, and liraglutide: A vigibase study
Article
作者: Yatsuya, Hiroshi ; Aleksic, Branko ; Ebina, Takumi ; Cabé, Nicolas ; Dolladille, Charles ; Savey, Véronique ; Onoue, Takeshi ; Nishida, Kazuki ; Chrétien, Basile
BACKGROUND:
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are crucial in managing type 2 diabetes mellitus (T2DM) and obesity. Agents like dulaglutide, semaglutide, and liraglutide mimic endogenous GLP-1, enhancing insulin secretion and promoting satiety. Beyond glycemic control, they offer cardioprotective and neuroprotective benefits. However, concerns about psychiatric adverse effects have emerged, necessitating a systematic assessment of their safety profile.
MATERIAL & METHODS:
This multinational pharmacovigilance study utilized VigiBase® data up to December 1, 2024, focusing on adverse drug reaction (ADR) reports for GLP-1 RAs. Psychiatric ADRs were classified using MedDRA terminology. Disproportionality analyses were conducted via logistic regression to calculate reporting adjusted Reporting Odds Ratios (aRORs) within reports involving antidiabetic or anti-obesity medications. A causal forest model assessed the individual treatment effect (ITE) of semaglutide on depression and suicidality reporting.
RESULTS:
Among 2,061,901 reports, 21,414 involved psychiatric ADRs for GLP-1 RAs. Significant signals were observed for anxiety (aROR: 1.26, 95%CI: 1.18-1.35), depressed mood disorders (aROR: 1.70, 95%CI: 1.57-1.84) and suicidality (aROR 1.45, 95%CI: 1.29-1.63) with semaglutide, and eating disorders with all three GLP-1 RAs (aRORs between 4.17 and 6.80). The causal forest model estimated an average treatment effect of 0.0046 for semaglutide on depression and suicidality reporting, with significant heterogeneity across regions and demographic groups.
DISCUSSION:
The study found no significant increase in overall psychiatric ADR reporting for GLP-1 RAs, except for eating disorders and depression/suicidality in semaglutide-treated patients. Sensitivity analyses before June 4, 2021, found no signals, aligning with RCT data. Post-marketing reports linked semaglutide to depression and suicidal ideation, prompting regulatory investigations. The causal forest model revealed significant heterogeneity in the psychiatric safety profile of semaglutide, with regional factors influencing ADR reporting.
CONCLUSION:
While GLP-1 RAs do not show a significant increase in overall psychiatric ADR reporting, findings suggest that clinicians should remain vigilant for potential depressive symptoms and suicidality, particularly in individuals with obesity treated with semaglutide since its approval for weight management.
2025-07-01Lancet Diabetes & Endocrinology
Once‑weekly IcoSema versus once‑weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open‑label, multicentre, treat‑to‑target, randomised, phase 3a trial
Article
作者: Terauchi, Yasuo ; Mathieu, Chantal ; Pagliaro Rocha, Thaís M ; Ramachandran, Ambady ; Ji, Linong ; Larsen, Jonas Hughes ; Shankarappa, Vinay Babu ; Giorgino, Francesco ; Kim, Sin Gon ; Philis-Tsimikas, Athena
BACKGROUND:
IcoSema is a once‑weekly combination therapy of basal insulin icodec (icodec) and semaglutide (a GLP‑1 analogue) currently in development. COMBINE 1 compared the efficacy and safety of IcoSema with once‑weekly icodec alone in adults with inadequately controlled type 2 diabetes on daily basal insulin therapy.
METHODS:
COMBINE 1, a 52‑week, open‑label, treat‑to‑target, randomised, phase 3a trial, was done at 192 outpatient clinics and hospital departments across 20 countries and regions. Individuals aged 18 years or older with a BMI of 40 kg/m2 or less and type 2 diabetes (HbA1c 7·0-10·0% [53·0-85·8 mmol/mol]) treated with daily basal insulin with or without oral glucose‑lowering medications were randomly assigned (1:1) via a randomisation and trial supply management system to IcoSema (700 U/mL plus 2 mg/mL) or icodec (700 U/mL), both administered as subcutaneous injections on the same day each week, at any time of the day. There was no stratification based on participants' baseline characteristics. The primary endpoint was change in HbA1c from baseline to week 52, evaluated in the full analysis set (all randomly assigned participants). The trial is registered with ClinicalTrials.gov, NCT05352815, and has been completed.
FINDINGS:
Between June 1, 2022, and March 13, 2023, 1671 individuals were screened, of whom 1291 (mean age 60·6 years [SD 10·3]; 799 [62%] males and 492 [38%] females) were randomly assigned to IcoSema (n=646) or icodec (n=645). At week 52, from a baseline value of 8·22% (SD 0·83; 66·3 mmol/mol [9·1]), estimated mean change in HbA1c was -1·55 percentage points (SE 0·03; -16·9 mmol/mol [0·4]) with IcoSema and -0·89 percentage points (SE 0·03]; -9·7 mmol/mol [0·4]) with icodec (estimated treatment difference [ETD] -0·66 percentages points [95% CI -0·76 to -0·57]; -7·3 mmol/mol [-8·3 to -6·2]; p<0·0001; superiority confirmed). The rate of combined clinically significant or severe hypoglycaemia from baseline to week 57 was significantly lower with IcoSema than with icodec (0·14 vs 0·63 episodes per person‑year of exposure; estimated rate ratio 0·22 [95% CI 0·14 to 0·36]; p<0·0001; superiority confirmed). The most frequently reported adverse events were within the system organ class of gastrointestinal disorders in the IcoSema group (303 [47%] of 644 participants had 1033 events during the trial) and infections and infestations in the icodec group (275 [43%] of 644 participants had 466 events. 59 (9%) participants in the IcoSema group and 69 (11%) participants in the icodec group had a serious adverse event. No treatment-related deaths occurred.
INTERPRETATION:
In adults with inadequately controlled type 2 diabetes on daily basal insulin therapy, once‑weekly IcoSema showed superiority to once-weekly icodec alone in changes in HbA1c and in overall lower rate of combined clinically significant or severe hypoglycaemia. IcoSema might provide an option for insulin therapy intensification in adults with type 2 diabetes.
FUNDING:
Novo Nordisk.
TRANSLATIONS:
For the Chinese and Japanese translations of the abstract see Supplementary Materials section.
100 项与 司美格鲁肽（齐鲁制药） 相关的药物交易
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