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NCT05134662
ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)
Phase 1 trial testing ALT-801 in Type 2 Diabetes in 55 participants. Completed in 9 March 2023.
3 February 2023
Quick facts
| Lead sponsor | Altimmune, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 1 February 2022 |
| Primary completion | 3 February 2023 |
| Estimated completion | 9 March 2023 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- ALT-801 — full drug profile →
- Placebo
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Altimmune, Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05134662
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ALT-801
Trials testing the same drug.
- NCT05295875 — Efficacy and Safety of ALT-801 in the Treatment of Obesity · Phase 2 · completed
- NCT05292911 — Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD) · Phase 1 · completed
- NCT05006885 — ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) · Phase 1 · completed
- NCT04561245 — ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability · Phase 1 · completed
- NCT01670994 — QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma · Phase 1, PHASE2 · terminated
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other Altimmune, Inc. trials
Trials by the same sponsor.
- NCT07009860 — RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated · Phase 2 · recruiting
- NCT05989711 — IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) · Phase 2 · completed
- NCT05295875 — Efficacy and Safety of ALT-801 in the Treatment of Obesity · Phase 2 · completed
- NCT05292911 — Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD) · Phase 1 · completed
- NCT05006885 — ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05134662 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Altimmune, Inc.
- Last refreshed: 24 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05134662.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing