Drugs / Pemvidutide
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04972396 | Sep 2021 → May 2022 | metabolic dysfunction-associated steatohepatitis | Altimmune, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07009860 | Jun 2025 → Mar 2027 expected | alcoholic liver disease | Altimmune, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06987513 | May 2025 → May 2026 overdue | alcohol-related disorders | Altimmune, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05989711 | Jul 2023 → Nov 2025 | metabolic dysfunction-associated steatohepatitis | Altimmune, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07795164 | Jul 2026 → Dec 2028 expected | metabolic dysfunction-associated steatohepatitis | Altimmune, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | Altimmune, Inc. | Results Altimmune Announces Positive Topline Results from RECLAIM Phase 2 Trial of Pemvidutide in Alcohol Use Disorder altimmune.com ↗
Pemvidutide 2.4 mg delivered a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial |
| 2026-05-28 | Altimmune, Inc. | Results Pemvidutide Demonstrates Significant Metabolic Improvements in Patients with MASH in New 48‑Week IMPACT Phase 2b Data Presented at EASL 2026 altimmune.com ↗
The findings demonstrated reductions in triglycerides and total cholesterol, along with improvements in weight, waist circumference and blood pressure, highlighting the broad impact of pemvidutide on key drivers of MASH. |
| 2026-05-27 | Altimmune, Inc. | Results New IMPACT Phase 2b Data Highlight Concurrent Improvements Across Multiple Non-Invasive Markers and qFibrosis-Measured Fibrosis Regression with Pemvidutide in MASH at EASL 2026 altimmune.com ↗ |
| 2026-01-05 | Altimmune, Inc. | Regulatory Altimmune Receives FDA Breakthrough Therapy Designation for Pemvidutide in MASH altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing therapies that address serious liver diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH). |
| 2025-12-19 | Altimmune, Inc. | Results Altimmune Announces that Pemvidutide Achieved Key Measures of Success at 48 Weeks in IMPACT Phase 2b MASH Trial altimmune.com ↗
Topline 48-week data from the IMPACT trial showed that treatment with pemvidutide achieved statistically significant improvements across treatment arms in key non-invasive tests (NITs), including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), versus placebo. |
| 2025-11-11 | Altimmune, Inc. | Results Altimmune Announces Publication of IMPACT Phase 2b Trial Data in The Lancet and Concurrent Late-Breaking Oral Presentation at AASLD The Liver Meeting® 2025 altimmune.com ↗
24-week data demonstrated significant MASH resolution and weight loss, and strong evidence of anti-fibrotic activity with a favorable tolerability profile |
| 2025-11-07 | Altimmune, Inc. | Results Altimmune Presents AI-Based Analysis of Liver Fibrosis Reduction from IMPACT Phase 2b Trial of Pemvidutide in MASH in Late-breaking Poster at AASLD The Liver Meeting® 2025 altimmune.com ↗
The AI-based pathology tool Liver Explore™ showed that pemvidutide treatment resulted in significant reductions in the proportionate areas of early, advanced and total liver fibrosis compared to placebo at 24 weeks. |
| 2025-08-19 | Altimmune, Inc. | Regulatory Altimmune Announces FDA Fast Track Designation for Pemvidutide in Alcohol Use Disorder (AUD) altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing peptide-based therapeutics for liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pemvidutide for the treatment of Alcohol Use Disorder (AUD). |
| 2025-08-12 | Altimmune, Inc. | Results Altimmune Announces Second Quarter 2025 Financial Results and Business Update altimmune.com ↗
New data from the IMPACT trial demonstrates potentially class-leading improvements in corrected T1 (cT1), an important marker of liver inflammation and fibrosis |
| 2025-06-26 | Altimmune, Inc. | Results Altimmune Announces Positive Topline Results from the IMPACT Phase 2b Trial of Pemvidutide in the Treatment of MASH altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced positive topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH). |
| 2025-05-08 | Altimmune, Inc. | Results Altimmune Presents New Analyses Predicting High Rates of MASH Resolution on Biopsy following Pemvidutide Treatment at the EASL International Liver Congress™ altimmune.com ↗
Applied to datasets from a previously completed trial with pemvidutide in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD), the MASHResInd predicted a high probability that MASH resolution would occur with pemvidutide treatment. |
| 2025-05-01 | Altimmune, Inc. | Results Altimmune to Present at Upcoming EASL International Liver Congress™ 2025 altimmune.com ↗
MASH resolution index, a novel, highly sensitive non-invasive measure of histologic improvement, predicts high rates of MASH resolution with pemvidutide treatment of metabolic dysfunction-associated steatohepatitis (MASH) |
| 2024-11-15 | Altimmune, Inc. | Results Altimmune Presents New Data on the Effect of Pemvidutide on Inflammatory Lipids in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) at The Liver Meeting® 2024 altimmune.com ↗
The data showed reductions in multiple classes of inflammatory lipid species associated with adverse cardiovascular outcomes. |
| 2024-11-07 | Altimmune, Inc. | Regulatory Altimmune Announces Successful Completion of End-of-Phase 2 Meeting with FDA for Pemvidutide in the Treatment of Obesity altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity. |
| 2024-10-15 | Altimmune, Inc. | Results Altimmune to Present New Data on the Lipidomic Profile in Subjects Treated with Pemvidutide at The Liver Meeting® 2024 altimmune.com ↗
new data showing reductions of multiple classes of atherogenic and cardio-inflammatory lipids in subjects treated with pemvidutide |
| 2024-09-10 | Altimmune, Inc. | Results CORRECTION – Altimmune Presents Results of a Phase 2 MRI-Based Body Composition Sub-Study at 60th Annual Meeting of the European Association for the Study of Diabetes altimmune.com ↗
Lean mass preservation was greater in subjects aged 60 years and older, in whom the lean loss ratio was only 19.9%. |
| 2024-09-03 | Altimmune, Inc. | Results Altimmune Announces Oral Presentation of Pemvidutide Clinical Data at 60th Annual Meeting of the European Association for the Study of Diabetes altimmune.com ↗
Pemvidutide preserves lean body mass during weight loss in patients with overweight and obesity: results of a phase 2, MRI-based body composition sub-study |
| 2024-07-25 | Altimmune, Inc. | Results Altimmune Announces Publication of Clinical Study of Pemvidutide in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Journal of Hepatology altimmune.com ↗
Weekly subcutaneous doses of pemvidutide resulted in up to 68.5% relative reduction in liver fat content (LFC), with up to 55.6% of subjects achieving LFC normalization after 12 weeks of treatment |
| 2024-06-23 | Altimmune, Inc. | Results Altimmune Presents Data from Phase 2 MOMENTUM Trial of Pemvidutide in Obesity during Oral Presentation at the American Diabetes Association’s 84th Scientific Sessions altimmune.com ↗
Full analysis of body composition data showed class-leading lean mass preservation with 21.9% of weight loss attributable to lean mass and 78.1% attributable to fat |
| 2024-06-22 | Altimmune, Inc. | Results Altimmune Presents Data on the Effect of Pemvidutide on Cardioinflammatory Lipids during Oral Presentation at American Diabetes Association’s 84th Annual Scientific Sessions altimmune.com ↗
Pemvidutide elicited significant weight loss and decreases in pro-inflammatory serum lipids associated with atherogenesis and cardiovascular disease risk |
| 2024-06-05 | Altimmune, Inc. | Results Altimmune Presents Data at EASL International Liver Congress™ 2024 Supporting the Disease Modifying Potential and Differentiated Therapeutic Profile of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH) altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today presented new data on the potential anti-inflammatory and anti-fibrotic properties of pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH) at the EASL International Liver Congress™ 2024 in Milan, Italy. |
| 2024-03-27 | Altimmune, Inc. | Results Altimmune Announces Positive Lean Mass Preservation Data for Pemvidutide and Reports Fourth Quarter and Full Year 2023 Financial Results altimmune.com ↗ |
| 2023-11-30 | Altimmune, Inc. | Results Altimmune Announces Positive Topline Results from MOMENTUM 48-Week Phase 2 Obesity Trial of Pemvidutide altimmune.com ↗
Over 50% of subjects achieved at least 15% weight loss and over 30% of subjects achieved at least 20% weight loss on the 2.4 mg dose. |
| 2023-10-26 | Altimmune, Inc. | Regulatory Altimmune Granted Fast Track Designation by FDA for Pemvidutide for the Treatment of Non-Alcoholic Steatohepatitis (NASH) altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program investigating pemvidutide for the treatment of NASH. |
| 2023-06-15 | Altimmune, Inc. | Results Altimmune Announces Oral Presentation of Pemvidutide Clinical Data in Treatment of NAFLD at Upcoming EASL International Liver Congress™ 2023 altimmune.com ↗
Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, Significantly Reduces Liver Fat, Fibro-inflammation, and Body Weight in Patients with Non-alcoholic Fatty Liver Disease: a 24-week Multicenter, Randomized, Double-blind, Placebo-controlled Trial (Presentation ID OS-063) |
| 2023-03-21 | Altimmune, Inc. | Results Altimmune Announces Positive Results from Week 24 Interim Analysis of Pemvidutide MOMENTUM Phase 2 Obesity Trial and 12-Week Phase 1b Type 2 Diabetes Safety Trial altimmune.com ↗ |
| 2023-01-04 | Altimmune, Inc. | Results Altimmune Announces Oral Presentation of Pemvidutide Clinical Data at Upcoming NASH-TAG Conference on January 7, 2023 altimmune.com ↗
Pemvidutide, a Balanced GLP-1/Glucagon Dual Receptor Agonist, Significantly Reduces Liver Fat, Non-invasive Markers of Fibroinflammation, and Body Weight in Patients with Non-alcoholic Fatty Liver Disease: Results of a Multicenter, Randomized, Double-blind, Placebo-controlled Trial |
| 2022-12-20 | Altimmune, Inc. | Results Altimmune Announces Positive Topline Results from 24-Week (12-Week Extension) Trial of Pemvidutide in Subjects with Non-Alcoholic Fatty Liver Disease (NAFLD) altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced topline results from its 24-week (12-week extension) trial of pemvidutide in subjects with NAFLD. |
| 2022-09-14 | Altimmune, Inc. | Results Altimmune Announces Significant Reductions in Liver Fat Content and Body Weight in 12-Week Phase 1b Clinical Trial of Pemvidutide in Subjects with NAFLD altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced positive topline results from its 12-week Phase 1b study of pemvidutide1 in subjects with non-alcoholic fatty liver disease (NAFLD). |
| 2022-01-31 | Altimmune, Inc. | Regulatory Altimmune Announces FDA Clearance of Pemvidutide (ALT-801) IND for Obesity altimmune.com ↗ |
| 2021-11-09 | Altimmune, Inc. | Results Altimmune Announces Third Quarter 2021 Financial Results and Provides a Corporate Update altimmune.com ↗
Exploratory MRI-PDFF analysis of subjects with hepatic steatosis in recently completed Phase 1 study of pemvidutide shows reduction of liver fat to undetectable levels after 6 weeks of treatment |
| 2021-09-28 | Altimmune, Inc. | Results Altimmune Announces Positive Results From 12-week Phase 1 Clinical Trial of ALT-801 (Pemvidutide) in Overweight and Obese Volunteers altimmune.com ↗
At 12 weeks, subjects receiving pemvidutide achieved mean weight losses of 4.9%, 10.3%, and 9.0% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, with the placebo group experiencing a mean weight loss of 1.6%. |
All press releases naming this drug 56 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pemvidutide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06987513 ↗ |
| Action | Activate | “GLP-1-glucagon dual receptor agonists such as pemvidutide have shown promise in treating metabolic dysfunction-associated steatohepatitis (MASH).” PMID 41237796 ↗ Nov 2025 |
| Route | Subcutaneous | “Injected subcutaneously (SC)” NCT04972396 ↗ |