ALTIMMUNE, INC. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-07-30: Study NCT07795164; Company role Lead sponsor; Phase Phase 3; Status Recruiting.
- 2025-06-16: Study NCT07009860; Company role Lead sponsor; Phase Phase 2; Status Active not recruiting.
- 2025-05-15: Study NCT06987513; Company role Lead sponsor; Phase Phase 2; Status Completed.
- 2023-07-27: Study NCT05989711; Company role Lead sponsor; Phase Phase 2; Status Completed.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-07-30 | NCT07795164 Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH | Lead sponsor | Phase 3 | Recruiting | Metabolic Dysfunction-Associated Steatohepatitis (MASH) | 1,800 | 2032-12 |
| 2025-06-16 | NCT07009860 RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) | Lead sponsor | Phase 2 | Active not recruiting | Alcohol-associated Liver Disease | 121 | 2027-09-30 |
| 2025-05-15 | NCT06987513 RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight | Lead sponsor | Phase 2 | Completed | Alcohol Use Disorder (AUD) | 100 | 2026-07-30 |
| 2023-07-27 | NCT05989711 IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) | Lead sponsor | Phase 2 | Completed | Non-Alcoholic Steatohepatitis (NASH) | 212 | 2025-11-25 |
| 2022-03-31 | NCT05295875 Efficacy and Safety of ALT-801 in the Treatment of Obesity | Lead sponsor | Phase 2 | Completed | Obesity/Overweight | 391 | 2023-09-28 |
| 2022-03-09 | NCT05292911 Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD) | Lead sponsor | Phase 1 | Completed | Non-Alcoholic Fatty Liver Disease | 64 | 2022-10-31 |
| 2022-02-01 | NCT05134662 ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM) | Lead sponsor | Phase 1 | Completed | Type 2 Diabetes | 55 | 2023-03-09 |
| 2021-09-30 | NCT05006885 ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) | Lead sponsor | Phase 1 | Completed | Non-Alcoholic Fatty Liver Disease | 95 | 2022-08-17 |
| 2021-09-15 | NCT04972396 Pemvidutide (ALT-801) DDI Study in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | NASH - Nonalcoholic Steatohepatitis | 40 | 2022-05-15 |
| 2021-02-25 | NCT04679909 Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study) | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 92 | 2022-12-21 |
| 2020-12-26 | NCT04684914 HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB) | Lead sponsor | Phase 2 | Terminated Results posted | Hepatitis B, Chronic | 87 | 2024-04-17 |
| 2020-11-10 | NCT04561245 ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability | Lead sponsor | Phase 1 | Completed | Obesity; Nonalcoholic Steatohepatitis | 100 | 2021-10-29 |
| 2020-10-10 | NCT04442230 NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19) | Lead sponsor | Phase 2 | Terminated Results posted | Coronavirus Infection | 48 | 2021-02-15 |
| 2020-06-15 | NCT04415749 NasoShield in Healthy Adults to Study Safety and Immunogenicity | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 43 | 2021-03-15 |
| 2019-01-21 | NCT03760549 Study of the Safety and Immunogenicity of NasoVAX Extension | Lead sponsor | Observational | Completed | Influenza | 8 | 2019-02-18 |
| 2018-01-18 | NCT03352466 NasoShield Study of Safety and Immunogenicity | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 145 | 2019-05-13 |
| 2017-09-18 | NCT03232567 Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX | Lead sponsor | Phase 2 | Completed Results posted | Influenza | 60 | 2018-06-15 |
| 2017-05-08 | NCT03163342 Immune Response Following Seasonal Influenza Vaccination | Lead sponsor | Phase 4 | Completed Results posted | Influenza | 20 | 2018-06-15 |
| 2015-07 | NCT02496897 Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B | Lead sponsor | Phase 1 | Completed Results posted | Hepatitis B | 61 | 2018-06-05 |
| 2010-12 | NCT01265745 Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects | Lead sponsor | Phase 1 | Completed | Anthrax | 28 | 2011-12 |
| 2010-07 | NCT01204866 Study of Valortim® (MDX-1303) and Its Selected Formulation Components Percutaneous Use | Lead sponsor | Phase 1 | Completed | Allergic Reactions | 5 | 2010-09 |
| 2009-08 | NCT00964561 Ph1 Study of Valortim and Ciprofloxacin in Humans | Lead sponsor | Phase 1 | Suspended | Anthrax | 26 | 2010-07 |
| 2009-07 | NCT00964834 Ph1 Study of Valortim and Doxycycline in Humans | Lead sponsor | Phase 1 | Terminated | Anthrax | 24 | 2009-12 |
| 2008-10 | NCT00755703 Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine. | Lead sponsor | Phase 1 | Completed | Influenza A Subtype H5N1 Infection | 48 | 2011-12 |
| 2008-09 | NCT00744146 First Time in Human Study of Protexia | Lead sponsor | Phase 1 | Completed | Intervention for Nerve Agent Exposure | 33 | 2009-11 |
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