GPD1 modulators(glycerol-3-phosphate dehydrogenase 1 modulators), PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseOther Diseases+ [8]

Active Indication

Differentiated Thyroid Gland CarcinomaDepressive DisorderHIV Infections+ [9]

Inactive Indication

Diabetes Mellitus, Type 2Ischemic stroke

Originator Organization

Elcelyx Therapeutics, Inc.

Active Organization

University of California, Los Angeles

Baylor College of MedicinePeking Union Medical College Hospital

+ [4]

Inactive Organization

Anji Pharmaceuticals, Inc.

National Institute on Drug Abuse

Elcelyx Therapeutics, Inc.

+ [2]

License Organization

Anji Pharmaceuticals (Shanghai) Co., Ltd.

Emory University

Elcelyx Therapeutics, Inc.

+ [3]

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Structure/Sequence

Molecular FormulaC4H11N5

InChIKeyXZWYZXLIPXDOLR-UHFFFAOYSA-N

CAS Registry657-24-9

416

Clinical Trials associated with Metformin

NCT07007221

/ Not yet recruitingPhase 2IIT

Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV

Depression in HIV occurs commonly and causes poor HIV outcomes with public health implications.
Depression prevalence in HIV-infected persons is estimated at 26% compared to 5% in the general population. Adherence to antiretroviral medication is a life-saving treatment in HIV, but depression can reduce engagement in care and adherence to medication. Depression is also associated with poorer levels of viral suppression and even mortality. Overall, those with depression and HIV are less likely to return to health and remain more likely to transmit the virus. therefore, treatment of HIV is essential to prevention; lower engagement in and adherence to HIV treatment due to depression puts others at risk. This is a 3 part trial, an initial pilot, a placebo controlled pilot, and a full trial.
Part 1. Dose response, Tolerability/Acceptability of Metformin for Depression in people with HIV: To do Initial assessment of metformin for depression in people with HIV we will perform a randomized, double blind, 2-arm, 12 week randomized controlled trial to assess feasibility and acceptability of metformin for depression. We will test two doses of metformin 1000 mg daily versus 1500 mg daily.
Part 2. Preliminary Efficacy Trial of Metformin for Depression in People with HIV: This will be a two-arm, double-blind trial of metformin versus placebo in people with HIV and depression. We will randomize individuals 1:1 to metformin or placebo. Will then collect blood and rectal swabs for preliminary assessments of the mechanism of action for metformin in people with HIV and depression.
Part 3. Full efficacy factorial trial of metformin for depression and comparison/interaction with fluoxetine in people living with HIV: To assess metformin and fluoxetine as efficacious treatments for depression in people with HIV, we will conduct a 4-arm, 12-week, mechanistic, double-blinded, randomized controlled treatment trial (RCT) with an assessment of inflammation and the gut microbiome. Participants (n=400) will be HIV- positive patients on ART with comorbid depression receiving care at one of two Ugandan clinics. In addition, we will use the NIMH Research Domain Criteria (RDoC) of Acute Threat and loss under Negative Valence using biomarkers and self-reported tools.

Start Date01 Jan 2026

Sponsor / Collaborator

University of Minnesota

TCTR20240817009

/ Not yet recruitingPhase 1

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin 50/1000 mg Film-coated Tablets and Reference Product (GALVUS MET (50 MG/1000 MG)) in Healthy Thai Volunteers under Fed Conditions

Start Date06 Feb 2025

Sponsor / Collaborator-

IRCT20220111053692N19

/ CompletedNot Applicable

Bioequivalence study of Metformin ER ??? mg Tablet (Tehran chemie) versus Glucophage® XR ??? mg (Merck-Brand) Tablet after single oral dosing in healthy volunteers

Start Date30 Dec 2024

Sponsor / Collaborator

Tehran Chemie Pharmaceutical Co.

100 Clinical Results associated with Metformin

100 Translational Medicine associated with Metformin

100 Patents (Medical) associated with Metformin

36,975

Literatures (Medical) associated with Metformin

01 Mar 2026·BIOMATERIALS

Senescence-regulating agents remodel mesenchymal stem cell-schwann cell circuitry for diabetic bone regeneration

Article

Author: Liu, Ziyang ; Mao, Jing ; Li, Weiqi ; Xu, Chenci ; Zhuang, Yu ; Sun, Yiting ; Lin, Kaili ; Ge, Linhu ; Wu, Xiangbing ; Wu, Jianyong ; Liu, Jiaqiang ; Lao, An

Bone healing requires Schwann cells (SCs) paracrine factors for mesenchymal stem cell function. Diabetes mellitus (DM) patients are susceptible to developing SCs dysfunction and impairing bone healing. Rare research considered reconstructing mesenchymal stem cell-schwann cell circuitry in diabetic bone regeneration. Here we found that SCs in diabetic microenvironment appeared cellular senescence phenotype with excessive reactive oxygen species (ROS) and mitochondrial dysfunction. To target at senescent SCs, we co-entrapped small interfering RNA that targets P53 (Si-P53) and metformin (MET) in ZIF-8-based nanoparticles (MMZ@Si-P53). Mechanistically, MMZ@Si-P53 affected senescent SCs by promoting mitochondria recovery and serine biosynthesis. In addition, rejuvenation of SCs and recovery of mesenchymal stem cell-schwann cell circuitry inhibited bone marrow mesenchymal stem cells (BMSCs) senescence and improved BMSCs ossification. Subsequently MMZ@Si-P53 loaded into glucose-responsive hydrogel system (MMZ@Si-P53/HAMA-PBA-PVA) for triggering release of nanoparticles in hyperglycemia. MMZ@Si-P53/HAMA-PBA-PVA strongly promoted diabetic bone regeneration in diabetic rat model. Our findings demonstrated the effectiveness of MMZ@Si-P53/HAMA-PBA-PVA system in repairing diabetic bone defects.

01 Feb 2026·Biomaterials advances

Metformin nanoparticles mitigate cerebral ischemia reperfusion injury by improving mitochondrial dysfunction and inhibiting NLRP3 activation

Article

Author: Li, Jiayu ; Guo, Sheng ; Tao, Tao ; Cai, Ting ; Song, Yinfei ; Deng, Lin

BACKGROUND:

Cerebral ischemia reperfusion injury (CIRI) is a serious condition that lacks highly effective treatment methods. After CIRI, microglia in the cortex of mice show high expression of CD44, which offers a potential target for the development of targeted drug-delivery systems to treat ischemic brain injury.

OBJECTIVE:

This study aimed to design a targeted drug-delivery system for ischemic brain injury, and explore the underlying molecular mechanisms on CIRI.

METHODOLOGY:

Hyaluronic acid-PEG-DSPE@metformin (HA@MET) nanoparticles were designed to specifically target the CD44 receptor on microglia. HA@MET was used to intervene in a CIRI mouse model, and then the infarct size and neurological scores were measured. Moreover, experiments on the expression of autophagy-related proteins (Beclin-1, Atg5, Sirt3), the production of reactive oxygen species (ROS), the activation of the NLRP3 inflammasome and the release of associated inflammatory factors (Caspase-1, IL-6, IL-1β) were performed.

RESULTS:

In the CIRI mouse model, HA@MET treatment led to a significant reduction in infarct size and an improvement in neurological scores, indicating a strong therapeutic effect on ischemic brain injury. Mechanistically, HA@MET inhibited the expression of key autophagy proteins Beclin-1 and Atg5, while increasing the expression of Sirt3 protein. This action alleviated excessive mitochondrial autophagy and promoted the clearance of damaged mitochondria. After entering microglia, HA@MET released metformin, which decreased ROS production and inhibited the activation of the NLRP3 inflammasome, resulting in reduced concentrations of inflammatory factors (Caspase-1, IL-6, IL-1β) and alleviating the inflammatory responses associated with CIRI.

CONCLUSIONS:

This study provides new perspectives and potential therapeutic targets for the treatment of ischemic brain injury. HA@MET, as a targeted drug-delivery system, shows promise in treating CIRI through multiple mechanisms, including regulating mitochondrial autophagy and inhibiting inflammation.

01 Feb 2026·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

A dual-modality sensor for pre-clicinal imaging of diabetes-associated copper dysregulation in vivo and in urine

Article

Author: Yang, Fangkun ; Jiang, Miaowei ; Chen, Shuqin ; Shang, Jinhui ; Li, Li ; Wang, Kai ; Wei, Hangbiao

Copper ions (Cu²⁺) play a critical role in physiological and pathological processes, including diabetes. However, detecting Cu²⁺ with high sensitivity and specificity in diabetes remains challenging. In this study, we developed a hemicyanine-based copper ion probe (CUP) encapsulated in mPEG-DSPE nanoparticles (CUNP) for dual-modality fluorescence and photoacoustic (PA) imaging of Cu²⁺. CUNP exhibited excellent aqueous solubility, biocompatibility, and a turn-on response to Cu²⁺, with activate signals. In vivo studies in streptozotocin (STZ)-induced diabetic mice revealed elevated hepatic Cu²⁺ levels, which were attenuated by metformin treatment, as confirmed by PA and fluorescence imaging. Urine analysis further revealed elevated Cu²⁺ in diabetic patients. These findings highlight CUNP as a promising tool for non-invasive Cu²⁺ monitoring in diabetes, with potential clinical applications in disease diagnosis and therapeutic evaluation.

124

News (Medical) associated with Metformin

17 Oct 2025

·www.prnewswire.com

FDA approves Novo Nordisk's oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event

Rybelsus® (semaglutide) tablets 7 mg or 14 mg, the only FDA-approved oral GLP-1 medicine available, now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as CV death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events1 In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to placebo, in addition to standard therapies Milestone underscores the robust data supporting oral semaglutide and demonstrates Novo Nordisk's cardiometabolic leadership and commitment to people living with chronic disease PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Oct. 17, 2025 /PRNewswire/ -- Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved Rybelsus®, the only oral GLP-1 medication available, for reducing the risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior CV event or not (primary and secondary prevention). Results of the SOUL trial reinforce the clinical profile of the semaglutide molecule, which has been studied across a variety of therapeutic areas.2 "Even in the absence of a previous heart attack or stroke, adults with type 2 diabetes face an increased risk of cardiovascular events, underscoring the need for therapies that go beyond managing blood sugar," said John B. Buse, MD, PhD, Distinguished Professor of Medicine, Director of the UNC Diabetes Care Center, and Steering Committee Co-Chair of the SOUL trial. "Having an oral GLP-1 therapy to help improve glycemic control was an innovation in and of itself. This new indication, based on the SOUL data, marks even further advancement and showcases the versatility of semaglutide while expanding options for millions of people." This new indication makes Rybelsus® the only oral GLP-1 medicine approved to reduce the risk of MACE in adults with type 2 diabetes who are at high risk for these events. It serves for both primary prevention (reducing the risk of major adverse cardiovascular events by preventing or managing risk factors in adults who are at high risk for these events) and secondary prevention (reducing the risk of another event in people who have had a serious CV event). The primary objective of the phase 3b SOUL trial was to evaluate the effects of oral semaglutide 14 mg, in addition to standard of care, on reducing the risk of MACE in adults with type 2 diabetes at high risk for major cardiovascular events. The primary endpoint of the study was the time to first occurrence of MACE (a 3-point composite of CV death, non-fatal myocardial infarction, or nonfatal stroke). MACE events occurred in 579/4825 participants (12.0%) of the semaglutide group and 668/4825 participants (13.8%) of the placebo group (HR 0.86; 95% CI, 0.77-0.96; p=0.006).2 Oral semaglutide 14 mg demonstrated a statistically significant 14% relative reduction in risk of MACE at 4 years (2% absolute risk reduction at 3 years) compared with placebo.2 These results add to the extensive body of randomized clinical trial and real-world evidence supporting semaglutide. "As the only FDA-approved GLP-1 therapy in a pill, now recognized for its proven cardiovascular benefits, a new benchmark has been set for future oral innovations," said Dave Moore, Executive Vice President, US Operations of Novo Nordisk Inc. "The semaglutide molecule has consistently demonstrated robust outcomes across multiple, large-scale trials, further reinforcing the already established cardiovascular profile it delivers for patients." The overall safety profile of oral semaglutide 14 mg in SOUL was consistent with that seen in previous trials, with safety data collection focused on serious adverse events, those of special interest, and those leading to discontinuation.2 The most common serious adverse events (SAEs) in the oral semaglutide 14 mg and placebo groups were cardiac disorders (17.8% and 19.8%, respectively) and infections/infestations (15.0% and 16.5%, respectively). SAEs were less common with oral semaglutide 14 mg (47.9%) than with placebo (50.3%), although there was a higher incidence of gastrointestinal disorders with oral semaglutide 14 mg (5.0% versus 4.4%). Adverse events that led to permanent discontinuation of oral semaglutide or placebo occurred in 749 participants (15.5%) in the oral semaglutide group and in 559 participants (11.6%) in the placebo group. Such events were mainly gastrointestinal disorders as well as infections or infestations.2 The FDA initially approved Rybelsus® in 2019 as the first and only GLP-1 medicine in pill form, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes.1 Separately, Novo Nordisk has also submitted a supplemental application in the US for a once-daily oral formulation of semaglutide under the trade name Wegovy® for the treatment of obesity. A decision is expected later this year. Only Novo Nordisk manufactures FDA-approved semaglutide medicines. Novo Nordisk is continuing to take multiple proactive measures to prevent both unlawful compounded and counterfeit versions of semaglutide. Novo Nordisk believes it is vitally important to make patients aware of the potential dangers of these unsafe and unapproved knockoff alternatives and informed of how to access authentic, FDA-approved Novo Nordisk semaglutide medicines. More information can be found on semaglutide.com. About SOUL SOUL was a multicenter, international, randomized, double-blind, parallel-group, placebo-controlled, phase 3b cardiovascular outcomes trial, with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide versus placebo, when added to standard of care, on cardiovascular outcomes in people with type 2 diabetes who are at high risk of MACE (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). The SOUL trial was initiated in 2019 with a mean follow up of 4 years. The primary outcome was time-to-first occurrence of major adverse cardiovascular events (MACE; a composite endpoint consisting of cardiovascular death, heart attack, and stroke).2 Oral semaglutide 14 mg demonstrated a statistically significant 14% relative reduction in risk of MACE at 4 years (2% absolute risk reduction at 3 years) compared with placebo.2 About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 receptor agonist indicated for the treatment of adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise.3,4 Rybelsus® is administered once daily and is currently available for use in two therapeutic dosages: 7 mg and 14 mg.5,6 Rybelsus® is currently commercially marketed in 45 countries. 2.4 million people have been prescribed Rybelsus® worldwide.7 What is RYBELSUS®? RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used: along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes mellitus who are at high risk for these events It is not known if RYBELSUS® is safe and effective for use in children Important Safety Information What is the most important information I should know about RYBELSUS®? RYBELSUS® may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS® and medicines that work like RYBELSUS® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people Do not use RYBELSUS® if: you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS®. See symptoms of serious allergic reaction in What are the possible side effects of RYBELSUS ®?" Before using RYBELSUS®, tell your healthcare provider if you have any other medical conditions, including if you: have or have had problems with your pancreas or kidneys have a history of vision problems related to your diabetes are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation) are pregnant or plan to become pregnant. It is not known if RYBELSUS® will harm your unborn baby. You should stop using RYBELSUS® 2 months before you plan to become pregnant are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS® Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS® may affect the way some medicines work and some medicines may affect the way RYBELSUS® works. How should I take RYBELSUS®? Take RYBELSUS® exactly as your healthcare provider tells you to Do not take more than 1 tablet each day Take RYBELSUS® by mouth on an empty stomach in the morning with a sip of plain water (no more than 4 ounces). Do not take RYBELSUS® with any other liquids besides water Do not split, crush, or chew. Swallow RYBELSUS® whole After 30 minutes, you can eat, drink, or take other oral medicines If you miss a dose of RYBELSUS®, skip the missed dose and go back to your regular schedule What are the possible side effects of RYBELSUS®? RYBELSUS® may cause serious side effects, including: inflammation of your pancreas (pancreatitis). Stop using RYBELSUS® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS® low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting or diarrhea that does not go away severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use RYBELSUS®. Tell your healthcare provider if you have stomach problems that are severe or will not go away serious allergic reactions. Stop using RYBELSUS® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat gallbladder problems. Gallbladder problems have happened in some people who take RYBELSUS®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include: pain in your upper stomach (abdomen), yellowing of skin or eyes (jaundice), fever, and clay-colored stools food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). RYBELSUS® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking RYBELSUS® before you are scheduled to have surgery or other procedures The most common side effects of RYBELSUS ® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start RYBELSUS®. Please click here for Prescribing Information and Medication Guide for RYBELSUS®. Please click here for Prescribing Information for Wegovy® including Medication Guide. About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com , Facebook , Instagram , and X . References Rybelsus® (oral semaglutide) [package insert]. Plainsboro, NJ: Novo Nordisk Inc. McGuire DK, Marx N, Mulvagh SL, et al. Oral semaglutide and cardiovascular outcomes in high-risk type 2 diabetes.N Engl J Med. 2025;392(20):2001-2012. Rybelsus® (oral semaglutide): US Prescribing Information. Available at: . Last accessed: October 2025. Rybelsus® (oral semaglutide): Summary of Product Characteristics. Available at: Rybelsus | European Medicines Agency (EMA). Last accessed: September 2025. Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated haemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 randomized clinical trial. JAMA. 2019;321(15):1466-1480. Rodbard HW, Rosenstock J, Canani LH, et al. Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin: the PIONEER 2 trial. Diabetes Care. 2019;42(12):2272-2281. Novo Nordisk Data on File. IQVIA Jun'25 Patients R3M Vol. data. 2025. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US25RYB00345 October 2025 SOURCE Novo Nordisk WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3

16 Oct 2025

·pharma.economictimes.indiatimes.com

Lilly's weight-loss pill shows better blood sugar control in late-stage trials

Bengaluru: Eli Lilly's experimental weight-loss pill showed superior blood sugar control in diabetic patients across two late-stage trials , the company said on Wednesday, as it seeks to widen its lead in the rapidly growing market for GLP-1 drugs . The oral drug, orforglipron, is designed to mimic the appetite-suppressing GLP-1 hormone targeted by the company's blockbuster injection tirzepatide, sold under the brand names Mounjaro and Zepbound. Lilly and its Danish rival Novo Nordisk, market leaders with their injectable drugs, are racing to launch oral weight-loss treatments, which still require approval by the U.S. Food and Drug Administration. In one of the studies, Lilly's pill helped lower A1C, a measure of blood sugar over time, by up to 1.7% compared to 0.8% with 10 mg dose of AstraZeneca's drug dapagliflozin, sold under the brand name Farxiga. The head-to-head trial was conducted in adults with type 2 diabetes inadequately controlled on metformin, a widely used drug to treat high blood sugar levels. In the other trial, orforglipron lowered A1C by an additional 2.1% when taken with insulin glargine. In both trials, orforglipron showed weight loss and improvements in multiple cardiovascular risk factors, the company said. Patients received either a 3 mg, 12 mg or 36 mg dose of orforglipron over 40 weeks across the studies. In a previous head-to-head trial in adults with type 2 diabetes, orforglipron lowered average blood sugar and weight more effectively than Novo's older GLP-1 pill Rybelsus. "Together, these results reinforce orforglipron's potential to become a new standard of care for people living with type 2 diabetes," said Jeff Emmick, senior vice president of product development, Lilly Cardiometabolic Health. Results from another trial is expected in the first quarter of 2026. Lilly plans to submit orforglipron for the treatment of type 2 diabetes to global regulatory agencies in 2026, while submission for the obesity treatment is set to occur by this year end. (Reporting by Sriparna Roy and Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)

Clinical ResultDrug Approval

15 Oct 2025

·endpoints.news

Lilly’s oral GLP-1 racks up two more clinical wins in diabetes

Eli Lilly’s GLP-1 pill has succeeded in two more late-stage trials in type 2 diabetes. The company said Wednesday that orforglipron beat AstraZeneca’s Farxiga at lowering patients’ blood sugar levels in one trial, and it topped placebo on the same measure in a different study in patients who were also taking insulin. The data bolster the case for the pill’s approval in diabetes that could come next year. In the trial designated ACHIEVE-2, the highest dose of Lilly’s drug cut A1C, a measure of glucose in a patient’s blood, by 1.6% after 40 weeks of treatment. Patients given Farxiga had an A1C reduction of 0.8%. Farxiga is an oral SGLT2 inhibitor approved to treat heart failure, but also to help type 2 diabetes patients control their blood glucose levels. Subjects in ACHIEVE-2 couldn’t maintain glycemic control despite taking metformin, the generic diabetes medication. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Sean Cole , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. The study tested three doses of orforglipron — 3 mg, 12 mg and 36 mg, each taken once per day. All doses of orforglipron hit statistical significance versus AstraZeneca’s drug on the A1C measure. Lilly said that the trial hit “all key secondary endpoints” too, showing “significant” weight loss as well as improvements in certain cardiovascular risk factors. It did not detail the data for the secondary endpoints. In the other study, named ACHIEVE-5, the same three doses of orforglipron were given alongside Lilly’s long-acting insulin Basaglar. The combo reduced blood sugar levels by 1.8% in patients who received the highest dose at 40 weeks. Patients given a placebo on top of Basaglar saw their blood sugar fall by 0.8%. Again, the difference was significant at all doses. The trial’s participants were permitted to take metformin and/or SGLT2 inhibitors as background therapy. Lilly’s pill already demonstrated a benefit in its first Phase 3 test in type 2 diabetes patients in April . Additional data backing this use arrived last month, when orforglipron beat Novo Nordisk’s rival GLP-1 pill Rybelsus in a head-to-head battle. The drug was roughly as safe and tolerable as it has been in prior trials, Lilly said. The new data come as a relief to the company after the pill disappointed in one obesity study earlier this year. In fairness, the product performed better in patients with both obesity and diabetes than in patients with obesity alone. There is one last study in the ACHIEVE suite of diabetes trials still left to read out. ACHIEVE-4 is testing the pill head-to-head against Basaglar, seeing if it can reduce the risk of cardiovascular events, including heart attacks, strokes and death. Data could come in the first half of next year. Lilly plans to seek approval of orforglipron for type 2 diabetes in 2026. First, though, it plans to submit an application for the drug’s use in obesity, with that filing coming this year. The drugmaker is also trialing the pill in obstructive sleep apnea, high blood pressure and osteoarthritis pain in adults with obesity.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Metformin

External Link

KEGG	Wiki	ATC	Drug Bank
-	Metformin	A10BA02	DB00331

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Differentiated Thyroid Gland Carcinoma	Phase 3	Poland	Medical Research Agency	01 Nov 2022
Ischemic stroke	Phase 3	United States	The Medical University of South Carolina	01 Oct 2008
Diabetes Mellitus, Type 2	Phase 3	United States	National Institute of Diabetes & Digestive & Kidney Diseases	01 May 2004
Depressive Disorder	Phase 2	-	University of Minnesota	01 Jan 2026
HIV Infections	Phase 2	-	University of Minnesota	01 Jan 2026
Monoclonal Gammopathy of Undetermined Significance	Phase 2	United States	Dana-Farber Cancer Institute, Inc.	27 Apr 2021
Plasma Cell Leukemia	Phase 2	United States	Dana-Farber Cancer Institute, Inc.	27 Apr 2021
Smoldering Multiple Myeloma	Phase 2	United States	Dana-Farber Cancer Institute, Inc.	27 Apr 2021
COVID-19	Clinical	United States	University of Minnesota	18 Aug 2022
Multiple Sclerosis	Preclinical	United States	University of California, Los Angeles	15 Oct 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02946996 (CTgov)	Phase 2	Prostatic Cancer \| Metastatic Prostate Carcinoma \| Adenocarcinoma of prostate	41	Metformin (Metformin Only)	yxjkykoyer(kjtbyclybx) = iztiudvqoc yvplcxsnhm (hbajuceeng, zjlsobfmhi - clapecabgy) View more	-	03 Feb 2025
				OPC (OPC Only)	yxjkykoyer(kjtbyclybx) = ueekfruobi yvplcxsnhm (hbajuceeng, ikzhchqfrh - dtwuqinweu) View more
NCT01107717 (EDICT \| EDICT study, CTgov)	Phase 4	Diabetes Mellitus, Type 2	318	exenatide+pioglitazone+metformin (Triple Therapy)	lzjgfaxzqp(gufxkemlce) = tkdrskxnet nanfqpxvvc (ggipzrngzi, 0.1) View more	-	05 Sep 2024
				glargine+metformin+glyburide (Conventional Therapy)	lzjgfaxzqp(gufxkemlce) = tugftrfttp nanfqpxvvc (ggipzrngzi, 0.1) View more
NCT04640571 (CTgov)	Phase 4	-	18	Metformin (Metformin)	eovhvzxsqq(pftspsovwu) = enexnxzkrv ezgulxwuco (avegfjdqkq, 34.1) View more	-	16 Jul 2024
				placebo+enalaprilat+pravastatin+valacyclovir+CDCA (Placebo)	eovhvzxsqq(pftspsovwu) = uqpeqtmcsx ezgulxwuco (avegfjdqkq, 24.7) View more
Corporate Publications Manual	Phase 3	Diabetes Mellitus, Type 2	-	恒格列净+二甲双胍 (恒格列净5 mg联合组)	lbupjqkxuw(adcrqszwzm) = iyuacrhtqu mrwliokjem (fikewmihfe ) View more	Positive	08 Jan 2024
				恒格列净+二甲双胍 (恒格列净10 mg联合组)	lbupjqkxuw(adcrqszwzm) = scbwlyirap mrwliokjem (fikewmihfe ) View more
NCT04899349 (EPIK-B4, CTgov)	Phase 2	Advanced breast cancer	2	Fulvestrant+Alpelisib+Dapagliflozin+Metformin XR+Dapagliflozin + metformin XR (Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR)	alafsbfqlk = sdtwyqhhzg apeljizavq (ytlrvnrnci, hpbzuilclk - biwjrcdzrm) View more	-	12 Dec 2023
				Fulvestrant+Alpelisib+Metformin XR (Alpelisib + Fulvestrant + Metformin XR)	umctmxgtej = difgznrgrz agqfiyvenq (ovruhszfiq, dbmscepzug - nlnrpwekjh) View more
FDA Manual	Not Applicable	Diabetes Mellitus, Type 2	1,091	Placebo	tmjismeoih(hxoetajcwl) = fpbcujlwil mteknjfont (rvfvxvsgxu ) View more	Positive	03 Nov 2023
				Sitagliptin 100 mg	tmjismeoih(hxoetajcwl) = xqrfvjmllx mteknjfont (rvfvxvsgxu ) View more
JPRN-UMIN000028405 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Solid tumor	41	Metformin+nivolumab	cukgcqsvaf(cvfkeyzcde) = drofzymfce kwkijcekyk (hwgnnwozwp ) View more	Positive	23 Oct 2023
NCT01968317 (CTgov)	Phase 2	Endometrioid intraepithelial neoplasia \| uterus adenocarcinoma	150	Megestrol acetat+metformin (Megestrol Acetate and Metformin)	wpaxkefhmc = lotjguiuyv ipsrlbucks (iemjgomvmq, hkadaepqog - hecwurpbvw) View more	-	13 Sep 2021
				megestrol acetate (Megestrol Acetate)	wpaxkefhmc = zmzfixnlzy ipsrlbucks (iemjgomvmq, xtdsczagze - dpqjnzccmx) View more
CTRI/2018/07/014865 (P-24, ESMO_GI2021)	Phase 1	Advanced Hepatocellular Carcinoma	40	Sorafenib 800mg	rwwzwptyfh(umlvhgyrxu) = sjfidgguya jxnaqnomzk (iaduifwskf ) View more	Positive	03 Jul 2021
				Sorafenib 600mg	koljtvgnqd(ufgqvkjucc) = aknnetirlu pgcfamgpel (rivqstsjbk, 1 - 11)
NCT02496741 (Pubmed \| Cancers (Basel)) Manual	Phase 1/2	IDH1 positive Solid Tumors IDH1 Mutation	12	Metformin+Chloroquine	kazvruvlig(ibymtporhq) = eqpfxasouy ykswisuqbw (bgyonunixj ) View more	Negative	19 May 2021

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