A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer.

Start Date17 Aug 2025

Sponsor / Collaborator

National Cancer Institute

NCT06732401 / Not yet recruitingPhase 3IIT

A Randomized Phase III Trial of Checkpoint Blockade in Lung Cancer Patients in the Adjuvant Setting Based on Pathologic Response Following Neoadjuvant Therapy (CLEAR)

This phase III trial compares the effect of adding AZD6738 to durvalumab versus durvalumab alone to increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery. AZD6738 may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Adding AZD6738 to durvalumab may increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery.

Start Date14 Mar 2025

Sponsor / Collaborator

National Cancer Institute

NCT06739122 / Not yet recruitingPhase 3

A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

Start Date01 Jan 2025

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Dulaglutide

100 Translational Medicine associated with Dulaglutide

100 Patents (Medical) associated with Dulaglutide

785

Literatures (Medical) associated with Dulaglutide

01 Jan 2025·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study

Article

Author: Reiss, Gary ; Bollepalli, Sureka ; Frias, Juan P ; Shringarpure, Reshma ; Tillman, Erik J ; de Temple, Brittany ; Harrison, Stephen A ; Zari, Arian ; Rolph, Timothy ; Cheng, Andrew ; Moulton, Ali ; Chan, Doreen ; Neff, Guy ; Su, Yan ; Lucas, K Jean ; Yale, Kitty

BACKGROUND & AIMS:

In phase 2 studies, efruxifermin, an Fc-FGF21 analog, significantly reduced steatohepatitis and fibrosis in patients with non-alcoholic steatohepatitis, now called metabolic dysfunction-associated steatohepatitis (MASH), for which there is no approved treatment. Type 2 diabetes (T2D) and obesity are prevalent among patients with MASH and increasingly treated with glucagon-like peptide-1 receptor agonists (GLP-1RAs). This study evaluated the safety and efficacy of efruxifermin in patients with MASH, fibrosis, and T2D taking a GLP-1RA.

METHODS:

Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks. The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA. Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.

RESULTS:

Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks. The addition of efruxifermin to a GLP-1RA appeared safe and well-tolerated. The most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events. One patient receiving efruxifermin discontinued due to nausea, and another withdrew consent. There were no treatment-related serious adverse events. After 12 weeks, efruxifermin reduced HFF by 65% (P < .0001 vs placebo) compared with a 10% reduction for placebo (GLP-1RA alone). Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.

CONCLUSIONS:

The tolerability profile of efruxifermin added to GLP-1RA appeared comparable to that of either drug alone, while also significantly reducing HFF and noninvasive markers of fibrosis in patients with MASH and T2D. Liver health in patients already on a GLP-1RA may be further improved by addition of efruxifermin.

CLINICALTRIALS:

gov, Number: NCT05039450.

01 Jan 2025·JOURNAL OF AFFECTIVE DISORDERS

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and suicidality: A replication study using reports to the World Health Organization pharmacovigilance database (VigiBase®)

Article

Author: Le, Gia Han ; Mansur, Rodrigo B. ; Rhee, Taeho Greg ; Rosenblat, Joshua D. ; McIntyre, Roger S ; Ho, Roger ; McIntyre, Roger S. ; Rosenblat, Joshua D ; Kwan, Angela T.H. ; Teopiz, Kayla M ; Wong, Sabrina ; Cao, Bing ; Kwan, Angela T H ; Teopiz, Kayla ; Mansur, Rodrigo B

INTRODUCTION:

Reports of suicidality associated with glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been reported to the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). We previously reported an increased reporting odds ratio (ROR) of some measures of suicidality with semaglutide and liraglutide using the FDA Adverse Event Reporting System (FAERS). Notwithstanding the increased ROR, causality between GLP-1 RAs exposure and any aspect of suicidality is not established.

RESEARCH DESIGN AND METHODS:

The analysis herein aims to extend a previous analysis of the FAERS by evaluating the ROR for suicidality reported to the World Health Organization (WHO) Pharmacovigilance Database (VigiBase). We aimed to characterize the ROR of suicidality associated with GLP-1 RAs, as extrapolated from spontaneous reports. As per our previous report, the ROR was considered significant when the lower limit of the 95 % confidence (CI) was >1.0.

RESULTS:

We searched VigiBase reports from inception to January 2024. The RORs for suicidal ideation were significantly increased for semaglutide (5.82), liraglutide (4.03) and tirzepatide (2.25). For "depression/suicidal", the ROR was significantly increased for semaglutide (14.74) and liraglutide (5.86); and for suicidal behaviour, the ROR was significantly increased for semaglutide (6.52) and liraglutide (3.90). However, for suicide attempts, the ROR was significantly decreased for semaglutide (0.11), dulaglutide (0.075), exenatide (0.047) and liraglutide (0.15). For completed suicide, the ROR was also significantly decreased for semaglutide (0.01), dulaglutide (0.003), exenatide (0.002) and liraglutide (0.008).

CONCLUSION:

Unlike our previous report with FAERS, a mixed pattern of ROR emerged in the WHO VigiBase with respect to suicidality and exposure to select GLP-RAs. Causation between GLP-1 RA exposure and suicidality (either increased or decreased) cannot be ascertained from ROR data.

01 Jan 2025·ANNALS OF PLASTIC SURGERY

Glucagon-Like Peptide-1 Agonists

Review

Author: Daar, David A. ; Hong, Kurt ; Koesters, Emma ; Manasyan, Artur ; Stanton, Eloise W. ; Banerjee, Rakhi

Background:

Glucagon-like peptide-1 (GLP-1) agonists, such as exenatide, liraglutide, dulaglutide, semaglutide, and tirzepatide, effectively manage type 2 diabetes by promoting insulin release, suppressing glucagon secretion, and enhancing glucose metabolism. They also aid weight reduction and cardiovascular health, potentially broadening their therapeutic scope. In plastic surgery, they hold promise for perioperative weight management and glycemic control, potentially impacting surgical outcomes.

Methods:

A comprehensive review was conducted to assess GLP-1 agonists' utilization in plastic surgery. We analyzed relevant studies, meta-analyses, and trials to evaluate their benefits and limitations across surgical contexts, focusing on weight reduction, glycemic control, cardiovascular risk factors, and potential complications.

Results:

Studies demonstrate GLP-1 agonists' versatility, spanning weight management, cardiovascular health, neurological disorders, and metabolic dysfunction-associated liver diseases. Comparative analyses highlight variations in glycemic control, weight loss, and cardiometabolic risk. Meta-analyses reveal significant reductions in hemoglobin A1C levels, especially with high-dose semaglutide (2 mg) and tirzepatide (15 mg). However, increased dosing may lead to gastrointestinal side effects and serious complications like pancreatitis and bowel obstruction. Notably, GLP-1 agonists' efficacy in weight reduction and glycemic control may impact perioperative management in plastic surgery, potentially expanding surgical candidacy for procedures like autologous flap-based breast reconstruction and influencing outcomes related to lymphedema. Concerns persist regarding venous thromboembolism and delayed gastric emptying, necessitating further investigation into bleeding and aspiration risk with anesthesia.

Conclusions:

GLP-1 agonists offer advantages in perioperative weight management and glycemic control in plastic surgery patients. They may broaden surgical candidacy and mitigate lymphedema risk but require careful consideration of complications, particularly perioperative aspiration risk. Future research should focus on their specific impacts on surgical outcomes to optimize their integration into perioperative protocols effectively. Despite challenges, GLP-1 agonists promise to enhance surgical outcomes and patient care in plastic surgery.

338

News (Medical) associated with Dulaglutide

23 Dec 2024

·www.globenewswire.com

CORXEL Acquires Worldwide (excluding Greater China) Rights to an Oral Small Molecule GLP-1 RA for the Treatment of Obesity and Diabetes

CORXEL expands its cardiometabolic pipeline into obesity and diabetesNEW JERSEY and SHANGHAI, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Corxel Pharmaceuticals (CORXEL), a leading biotech company committed to bringing innovative science and medicines to underserved patients with cardiometabolic diseases around the world, today announced the acquisition of CX11 (also known as VCT220), an oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA), for worldwide (excluding Greater China) development and commercialization, from Vincentage. CX11 is an investigational, oral small molecule GLP-1 RA for the treatment of cardiometabolic diseases, including obesity and type 2 diabetes. GLP-1 RAs have been shown to lower bodyweight, improve insulin sensitivity, and reduce glucose and overall appetite. CX11, in a once daily orally available formulation, could offer convenience and accessibility to patients, and lower the cost of manufacturing compared to injectables. In a Phase 2 clinical trial conducted in China, CX11 demonstrated competitive weight loss with favorable safety and tolerability. The registrational Phase 3 study in obese and overweight patients in China has been initiated in November 2024. CORXEL plans to initiate a global (excluding Greater China) Phase 2 study in obese and overweight patients in 2025. “Obesity has become a major risk factor for a number of chronic diseases like diabetes, hypertension, liver disease, and also including cardiovascular diseases such as heart disease and stroke, which are the leading causes of death worldwide. This acquisition marks CORXEL’s expansion of its cardiometabolic pipeline into obesity and diabetes, and we are excited about the potential of CX11, which has shown impressive efficacy in weight reduction, making it a potential best-in-class oral small molecule GLP-1 RA,” said Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL. “Since its establishment, CORXEL has proven its strong capabilities in asset selection, clinical development, registration and partnering in manufacturing for innovative medicines. Our global team is fully committed to developing CX11 with high quality and efficiency, allowing CORXEL to tap into the tremendous obesity market worldwide.” “We are very delighted that CORXEL will be advancing the global development of VCT220 (CX11). CORXEL has strong clinical development capabilities and global promotional strengths. We look forward to CORXEL accelerating the clinical trials and bringing this innovative oral GLP-1 molecule to patients worldwide in the future,” said Ben Li, Chief Executive Officer of Vincentage. About CORXEL CORXEL is a leading biotech company headquartered in US and China focused on developing innovative cardiometabolic therapies globally. CORXEL was founded in 2019 and has been committed to bringing innovative science and medicines to underserved patients around the world. With a strong and further developing asset pipeline, industry leading talent, and patient-centric focus, CORXEL is dedicated to delivering a meaningful and lasting impact on patients.  The portfolio of CORXEL consists of 3 assets with global rights and 2 assets with Greater China rights in late-stage clinical development. The portfolio with global rights covers CX11 for obesity and diabetes, JX10 for acute ischemic stroke (AIS) and JX09 for hypertension, while the portfolio with Greater China rights includes Etripamil and LNZ100. For further information about CORXEL, please visit www.corxelbio.com   Media contact: media@corxelbio.com About Vincentage Vincentage is a clinical-stage biotech, focusing on developing novel small molecule drugs for metabolic diseases. The company has developed small molecule innovative drugs targeting different mechanisms and targets for metabolic-related diseases, such as diabetes, obesity, and MASH.

Phase 2Acquisition

23 Dec 2024

·www.pharmaceutical-technology.com

FDA approves Lilly’s obesity med Zepbound to treat obstructive sleep apnoea

OSA is usually treated with a mask worn during sleep, called a continuous positive airway pressure (CPAP) machine. Credit: Kateryna Mostova via Shutterstock. Eli Lilly’s blockbuster obesity drug, Zepbound (tirzepatide), has secured a label expansion from the US Food and Drug Administration (FDA) for adults with obesity and moderate to severe obstructive sleep apnoea (OSA). A common sleep disorder characterised by repeated interruptions in breathing during sleep due to airway relaxation and narrowing, OSA is associated with obesity and aging and can lead to significant health complications, including cardiovascular issues and impaired quality of life. The condition is usually treated with a mask worn during sleep, called a continuous positive airway pressure (CPAP) machine. However, Zepbound has become the first prescription medication approved to treat OSA. The FDA’s decision was informed by data from the SURMOUNT-OSA Phase III trials (NCT05412004). These studies evaluated Zepbound’s effectiveness in reducing breathing disruptions over the course of one year in adults with obesity, both with and without positive airway pressure (PAP) therapy. After one year, 42% of Zepbound users without PAP therapy and 50% with PAP therapy achieved remission or mild, non-symptomatic OSA, compared to 16% and 14% in placebo groups, respectively. In the announcement accompanying the approval, Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA said: “Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences.” Lilly has also said that Zepbound helped patients lose an average of 45 lbs, or 18% of their body weight, in the same studies. Patients who received both Zepbound and PAP therapy lost an average of 50 lbs, or 20% of their body weight, the company added. This is compared to 4 lbs and 6 lbs on placebo, respectively. The FDA approval comes amid growing discussion about the potential uses of weight loss drugs beyond treating obesity and diabetes. In addition to sleep apnoea, there has been increasing interest in exploring their potential to treat neurodegenerative disorders as well as respiratory disease and more. Zepbound, a GLP-1 receptor agonist (RA), was initially approved in November 2023 for obesity management. It is also marketed under the brand name Mounjaro for type 2 diabetes. GLP-1 RAs, including tirzepatide and Novo Nordisk ’s semaglutide (marketed as Wegovy and Ozempic), have seen rapid adoption due to their demonstrated efficacy in weight loss and glycaemic control. Eli Lilly reported combined sales of $5.4bn for Zepbound and Mounjaro in 2023, and projections from GlobalData suggest these figures could climb to $62.6bn by 2030, driven by demand and additional label expansions. GlobalData is the parent company of Pharmaceutical Technology.

Phase 3Drug ApprovalClinical Result

11 Dec 2024

·www.drugs.com

Dupilumab Efficacious for Atopic Dermatitis in Young Children

WEDNESDAY, Dec. 11, 2024 -- Dupilumab treatment improves signs and symptoms of atopic dermatitis (AD) in young children, according to a study published in the December issue of Advances in Therapy . Mark Boguniewicz, M.D., from University of Colorado School of Medicine in Aurora, and colleagues evaluated the impact of type 2 comorbidities on the response to and safety of dupilumab in young children with AD. The analysis included children (aged 6 months to 5 years) with moderate-to-severe AD. The researchers found that at week 16, significantly more patients receiving dupilumab versus placebo, with or without asthma and allergic rhinitis (AR), achieved an Investigator’s Global Assessment (IGA) score of 0/1 and a ≥75 percent improvement in the Eczema Area and Severity Index. Significantly more patients receiving dupilumab with food allergies (FAs) and numerically more patients without FAs achieved an IGA score of 0/1 versus placebo. Compared with those taking placebo, numerically more patients receiving dupilumab with asthma and significantly more patients without asthma achieved a ≥4-point reduction in the weekly average of the daily score on the Worst Scratch/Itch Numeric Rating Scale (WSI-NRS). Similarly, a ≥4-point reduction in the weekly average of the daily score on the WSI-NRS was achieved by significantly more patients receiving dupilumab than placebo with or without AR and with or without FAs. Safety was consistent with the known dupilumab safety profile. "These results suggest that dupilumab treatment may be effective in children with or without other type 2 conditions," the authors write. The study was funded by Sanofi and Regeneron, which manufacture dupilumab. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Dulaglutide

External Link

KEGG	Wiki	ATC	Drug Bank
D09889	Dulaglutide	A10BJ05	DB09045

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	Eli Lilly & Co.	18 Sep 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypoglycemia	Phase 3	JP	Eli Lilly & Co.	13 Apr 2021
Chronic Kidney Diseases	Phase 3	US	Eli Lilly & Co.	01 Jul 2012
Chronic Kidney Diseases	Phase 3	BR	Eli Lilly & Co.	01 Jul 2012
Chronic Kidney Diseases	Phase 3	HU	Eli Lilly & Co.	01 Jul 2012
Chronic Kidney Diseases	Phase 3	MX	Eli Lilly & Co.	01 Jul 2012
Chronic Kidney Diseases	Phase 3	PL	Eli Lilly & Co.	01 Jul 2012
Chronic Kidney Diseases	Phase 3	RO	Eli Lilly & Co.	01 Jul 2012
Chronic Kidney Diseases	Phase 3	ZA	Eli Lilly & Co.	01 Jul 2012
Chronic Kidney Diseases	Phase 3	ES	Eli Lilly & Co.	01 Jul 2012
Chronic Kidney Diseases	Phase 3	UA	Eli Lilly & Co.	01 Jul 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACAAI2024	Not Applicable	Job Syndrome \| Dermatitis, Atopic IgE levels	-	Dupilumab	yfcoijvgyr(vtvlkqmfwe) = zdhvttnzeh ukprdmqcoh (fohzhipfpy )	Positive	24 Oct 2024
CRUISER (ASTRO2024)	Phase 2	Non-small cell lung cancer stage III	35	Concurrent durvalumab and CRT	xgcbgyfzqj(osowkblgvf) = Grade â¥3 imAE occurred in 4(11.4%) of 35 pts bbfgwkwklq (mmkxldbzwk )	Positive	01 Oct 2024
				Induction therapy
Phase III PACIFIC trial (ASTRO2024)	Phase 3	Pulmonary Disease, Chronic Obstructive \| Diabetes Mellitus \| Pneumonia ... Adjuvant View more	1,524	Durvalumab	bcetjplznu(hhcgspcsdo) = ikligdtbye vfuxlcejxg (ctwukhvddp ) View more	Positive	01 Oct 2024
				Placebo	bcetjplznu(hhcgspcsdo) = rdntunkcve vfuxlcejxg (ctwukhvddp )
ASTRO	Not Applicable	-	-	Durvalumab + Chemoradiotherapy	eujycjcsvv(nwmnlddjub) = 14 (32.6%) patients with grade 3 or 4 adverse events in which 5 patients were immune-related trgetutogn (pocjhctbqg )	-	01 Oct 2024
				Historical Control Group (Chemoradiotherapy only)
ASTRO	Not Applicable	Locally Advanced Lung Carcinoma	-	Definitive RT with concurrent and consolidative durvalumab	dtcynrfxkg(unhixuyfbi) = ldhwghfolr gjxdvdpect (fzegqdcwcz ) View more	-	01 Oct 2024
ASTRO	Not Applicable	Radiation Pneumonitis	-	Durvalumab	vtjlicgvkh(tujcvuafro) = Pneumonitis was recorded in 35 pts. (29.4%): G1-12; G2-18; G3-3; G4-1; G5-1. DURV was interrupted due to pneumonitis in 24 pts. (20%) and was not resumed in 17 pts. (14.3%). Median time to pneumonitis was 2.6 months (range 0.3-11) and risk decreased over time (HR 0.93, p<0.001). ibefvapnco (iapyzlgiyb ) View more	-	01 Oct 2024
ESC2024	Not Applicable	Diabetes Mellitus, Type 2	-	Dulaglutide and Dapagliflozin	zlgpoikhff(wolsrzaufo) = ziujhkfdnq urwslebktz (hkwcqhqxte, 47)	-	01 Sep 2024
				DPP-4 inhibitors	zlgpoikhff(wolsrzaufo) = onpfalxqsc urwslebktz (hkwcqhqxte, 60)
ADA2024	Not Applicable	Nonalcoholic Steatohepatitis	-	Dulaglutide	nmwefabpyf(rlwcndzrze) = gacitieapg gtzhaofydz (oggbdawxhr, 5) View more	-	14 Jun 2024
				Placebo	nmwefabpyf(rlwcndzrze) = wnqtjwxdkh gtzhaofydz (oggbdawxhr, 4)
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	Dulaglutide	atqlsbqatz(gwpzujhvas) = Four patients experienced dyspnea (28.6%) fgyasizkqi (zufpifadoy ) View more	-	14 Jun 2024
				Tirzepatide

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