Altimmune
Compare Altimmune…Clinical-stage biotech. Pemvidutide: GLP-1/glucagon dual agonist for obesity and MASH. Pivotal MASH IMPACT data expected 2026. MASH-first positioning differentiates from obesity-focused peers.
SectorsGLP-1
Register for a premium account to gain access to Sterling AI.
Get StartedThings you can ask Sterling:
AltimmuneClinical-stage biotech. Pemvidutide: GLP-1/glucagon dual agonist for obesity and MASH. Pivotal MASH IMPACT data expected 2026. MASH-first positioning differentiates from obesity-focused peers.
| Endpoint / Trial Arm | Dose / Comparator | Result |
|---|---|---|
| IMPACT MASH primary endpoint: MASH resolution without fibrosis worsening (24 weeks, ITT) | 1.2mg pemvidutide weekly | 59.1% MASH resolution at week 24 vs 19.1% placebo (p<0.0001); met the primary endpoint |
| IMPACT MASH primary endpoint: MASH resolution without fibrosis worsening (24 weeks, ITT) | 1.8mg pemvidutide weekly | 52.1% MASH resolution at week 24 vs 19.1% placebo (p<0.0001); resolution was not dose-ordered (the 1.2mg arm scored numerically higher than 1.8mg) |
| IMPACT MASH secondary endpoint: fibrosis improvement >=1 stage without MASH worsening (24 weeks, ITT) | 1.2mg / 1.8mg vs placebo | 31.8% (1.2mg) and 34.5% (1.8mg) vs 25.9% placebo at week 24; differences were not statistically significant (the trial was not powered for fibrosis improvement at this 24-week duration) |
| IMPACT MASH liver fat reduction (MRI-PDFF, 24 weeks) | 1.2mg / 1.8mg vs placebo | 58.0% (1.2mg) and 62.8% (1.8mg) relative reduction in liver fat vs 16.2% placebo (p<0.001 both doses) |
| IMPACT MASH weight loss (secondary endpoint, 24 weeks) | 1.2mg / 1.8mg vs placebo | -5.0% (1.2mg) and -6.2% (1.8mg) mean weight loss vs -1.0% placebo at 24 weeks (p<0.001 both doses) |
| IMPACT MASH 48-week extension (weight loss) | 1.2mg / 1.8mg vs placebo | Dec 2025 readout: -4.5% (1.2mg) and -7.5% (1.8mg) mean weight loss vs -0.2% placebo at 48 weeks (p<0.0001 both doses), with no weight-loss plateau at the 1.8mg dose. The primary histology endpoints were assessed at 24 weeks; the 48-week data covered secondary and non-invasive markers (ELF, liver stiffness) |
| IMPACT MASH tolerability | Adverse-event discontinuations | 0.0% (1.2mg) and 1.2% (1.8mg) vs 2.4% placebo; among the lowest discontinuation rates reported for an incretin in MASH |
| MOMENTUM obesity Phase 2 (48 weeks): high-dose cohort | 2.4mg pemvidutide weekly | Nov 2023 topline: 15.6% mean weight loss at 48 weeks at the high dose; competitive with semaglutide STEP 1 (~14.9% at 68 weeks). GI tolerability profile broadly comparable to other GLP-1 agonists |
| PERFORMA MASH Phase 3 (pivotal, registrational) | Phase 3 program | PERFORMA Phase 3 trial planned to initiate 2H 2026 (Altimmune EASL 2026 update); pivotal MASH biopsy + fibrosis-improvement co-primary endpoints; FDA Fast Track + Breakthrough Therapy Designation granted for MASH. Competing with Rezdiffra (already approved March 2024), survodutide (Phase 3), and semaglutide in MASH (FDA-approved August 2025) |
| MOMENTUM Phase 3 obesity (registrational) | Phase 3 program | Pivotal trial design + dose selection finalizing 2025; supports a separate obesity FDA filing pathway; target launch 2029-2030 if approved |
| Editorial. Why ALT matters | Strategic context | Altimmune is the smallest standalone biotech with parallel MASH + obesity Phase 3 ambitions. The dual GLP-1/glucagon mechanism is mechanistically distinct, but the development timeline (2028-2029 launches) puts ALT well behind the commercial-stage leaders. Pemvidutide MASH faces a crowded competitive field: Rezdiffra (oral, mechanistically distinct THR-beta), semaglutide (approved for MASH), survodutide (Phase 3), efruxifermin (AKRO, FGF21). The strategic question: standalone commercial launch vs acquisition (NVO + Roche + Boehringer have all been speculated as potential acquirers given the dual-mechanism asset profile) |
| Dose Arm | Patient Count + Duration | Weight Loss + Tolerability Result |
|---|---|---|
| Placebo | ~98 patients (391 total across 4 arms); 48 weeks | Mean weight loss 2.2% at 48 weeks |
| Pemvidutide 1.2mg weekly | ~98 patients; 48 weeks | Mean weight loss 10.3% at 48 weeks (placebo-adjusted ~8.1 points) |
| Pemvidutide 1.8mg weekly | ~98 patients; 48 weeks | Mean weight loss 11.2% at 48 weeks (placebo-adjusted ~9.0 points); weight loss was nearly flat between the 1.2mg and 1.8mg arms |
| Pemvidutide 2.4mg weekly (high dose) | ~98 patients; 48 weeks | Mean weight loss 15.6% at 48 weeks (placebo-adjusted ~13.4 points); over 50% of participants achieved >=15% weight loss and over 30% achieved >=20%; the high-dose result is the headline efficacy signal |
| Safety + secondary endpoints | Pooled active arms | GI adverse events were dose-related; robust reductions in serum lipids and improvements in blood pressure; glucose homeostasis maintained (no significant change in fasting glucose or HbA1c); no MACE and no cardiac-AE imbalance versus placebo |
| Cross-trial comparison (informational) | Efficacy + duration | Pemvidutide 15.6% at 48 weeks vs semaglutide STEP 1 ~14.9% at 68 weeks vs tirzepatide SURMOUNT-1 ~22% at 72 weeks vs MariTide ~20% at 52 weeks vs CagriSema 22.7% at 68 weeks. Cross-trial comparison is flawed due to different timeframes + patient cohorts; pemvidutide at 48 weeks is competitive but has not yet demonstrated longer-duration durability |
| Phase 3 obesity program | Phase 3 registrational pathway | Pemvidutide obesity Phase 3 program advancing in parallel with the MASH program; dose selection informed by MOMENTUM and the FDA End-of-Phase-2 meeting; 72-week registrational design (exact dose arms and start timing per Altimmune guidance) |
| Editorial. Why this readout matters | Strategic context | MOMENTUM established pemvidutide as a clinically meaningful obesity asset and validated the dual GLP-1/glucagon mechanism for monotherapy weight loss. The Phase 3 readout will determine whether pemvidutide can match semaglutide's commercial profile (~14-15%) or compete with tirzepatide's higher-efficacy class (~22%). The acquisition speculation cycle (NVO + Roche + Boehringer have all been linked to ALT at various points) intensifies as Phase 3 progresses |
2018-Q2-2021-Q4
2005-2025
$ALT
Pemvidutide: GLP-1/glucagon dual agonist for obesity and MASH. Phase 2b MASH IMPACT data expected 2026. MASH-first positioning differentiates from obesity-focused peers.