Amgen
Compare Amgen…Large-cap biopharma. MariTide: antibody-peptide conjugate combining GLP-1 agonism with GIPR antagonism, monthly or less frequent dosing. Phase 3 readout expected late 2026.
SectorsGLP-1
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AmgenLarge-cap biopharma. MariTide: antibody-peptide conjugate combining GLP-1 agonism with GIPR antagonism, monthly or less frequent dosing. Phase 3 readout expected late 2026.
| Trial / Cohort | Dose / Frequency | Key Endpoint Result |
|---|---|---|
| Phase 1 SAD (single ascending dose) | Multiple doses | 2022-2023 readouts; demonstrated dose-related weight reduction in obesity; supports Phase 2 advancement; pharmacokinetic profile supports monthly dosing |
| Phase 2 (obesity, 52 weeks): low-dose cohort | 140mg Q4W (monthly) | Dec 2024 topline: ~14.5% mean weight loss at 52 weeks; moderate GI tolerability profile; demonstrates dose-response curve |
| Phase 2 (obesity, 52 weeks): mid-dose cohort | 280mg Q4W (monthly) | Dec 2024 topline: ~17% mean weight loss at 52 weeks; more pronounced GI adverse events; supports dose-titration approach in Phase 3 |
| Phase 2 (obesity, 52 weeks): high-dose cohort | 420mg Q4W (monthly) | Dec 2024 topline: ~19.5-20% mean weight loss at 52 weeks; no plateau observed (suggesting longer dosing could go higher); ~75-80% GI adverse-event rate + ~30%+ discontinuation rate |
| Phase 2 (T2D cohort, 52 weeks) | Multiple doses | Dec 2024 topline: dose-related HbA1c reduction (high dose ~2.2% at 52 weeks) + 12-14% weight loss; lower GI adverse-event rates than obesity cohort |
| Phase 3 MARITIME-1 (obesity registrational) | Multiple doses; Phase 3 program | Initiated H1 2025; targets FDA approval 2027-2028; pivotal trial for monthly dosing convenience claim + GIP-antagonism efficacy claim |
| Phase 3 MARITIME-2 (T2D registrational) | Multiple doses | Initiated H1 2025; parallel approval pathway; separate T2D label |
| Phase 3 MARITIME-3 (cardiovascular outcomes) | Long-duration; CV endpoints | Cardiovascular outcomes trial to support cardiovascular-risk reduction labeling; supports premium positioning vs tirzepatide + semaglutide |
| Phase 2 MASH cohort | MASH indication | Additional indication; topline 2026; supports MASH expansion strategy |
| Competitive comparison | Efficacy + tolerability + dosing | Wegovy ~15% / 68 weeks (weekly); Zepbound ~22% / 72 weeks (weekly); MariTide ~20% / 52 weeks (monthly). MariTide's faster onset + monthly convenience trade-off against higher GI rates. Phase 3 readouts (2027-2028) settle the competitive question |
| Editorial. Why MariTide matters | Strategic context | MariTide is the only credible monthly-or-less-frequent GLP-1 in late-stage development, distinguishing it from the weekly-dosing peptide standard. If GI tolerability can be managed in Phase 3 via dose titration, MariTide becomes the convenience leader. If not, MariTide remains a high-efficacy product for patients who can tolerate it. The Phase 3 outcome shapes a multi-billion-dollar revenue opportunity for Amgen |
| Trial / Indication | Design + Sample Size | Enrollment Status + Readout Timeline |
|---|---|---|
| MARITIME-1 (Phase 3 obesity, registrational) | 3,853 patients (ClinicalTrials.gov, actual); multiple dose arms; 72-week primary endpoint | Phase 3 started March 2025 (NCT06858839); enrollment complete (ClinicalTrials.gov status ACTIVE_NOT_RECRUITING, 3,853 participants); primary completion estimated January 2027 per ClinicalTrials.gov; topline late 2026 to early 2027; FDA approval target 2027-2028 |
| MARITIME-1 design details | Dose-titration + placebo controlled | Pivotal trial uses progressive dose escalation to mitigate the ~75-80% GI adverse-event rate seen in Phase 2; primary endpoints: mean percent weight loss + proportion of patients achieving >=5% / >=10% / >=15% weight loss thresholds at 72 weeks; key secondary endpoint: discontinuation rate due to adverse events |
| MARITIME-2 (Phase 3 T2D, registrational) | T2D Phase 3 registrational | Phase 3 T2D program initiated H1 2025; primary endpoint HbA1c reduction + weight loss at 52-72 weeks; topline 2027; parallel approval pathway alongside obesity |
| MARITIME-3 (cardiovascular outcomes) | Cardiovascular outcomes Phase 3 | CVOT supporting CV-risk-reduction labeling claim (similar to semaglutide SELECT); long-duration outcomes; readout 2028-2029; supports premium positioning vs tirzepatide + semaglutide |
| MariTide OSA (obstructive sleep apnea) | OSA indication; Phase 2 expansion | Phase 2 expansion cohort evaluating MariTide in OSA (a fast-following indication that semaglutide + tirzepatide are pursuing); supports label expansion + commercial breadth |
| Manufacturing scale-up | Antibody-peptide conjugate scale | MariTide's antibody-peptide-conjugate structure requires distinct manufacturing capabilities vs peptide-only competitors; Amgen has invested in scale-up of biologics capacity at Rhode Island + Ohio sites supporting both BLA filing requirements + commercial-launch volumes (~$1-2B in dedicated MariTide manufacturing capex per analyst estimates) |
| Editorial. Why enrollment matters | Strategic context | MariTide's monthly-or-less-frequent dosing remains the headline product differentiation against weekly Wegovy + Zepbound. If MARITIME-1 demonstrates manageable GI tolerability via dose-titration, MariTide can launch 2027-2028 as the convenience leader. If GI burden remains prohibitive in Phase 3 despite dose-titration, MariTide becomes a niche high-efficacy product for patients who can tolerate it. The enrollment cadence (full enrollment late 2025 vs early-mid 2026) determines whether MariTide launches into a tirzepatide-dominated market or alongside competitive Phase 3 launches (CT-388, retatrutide, survodutide) |
2021-Q1-2025-Q4
2021-Q1-2025-Q4
1994-2025
$AMGN
MariTide: differentiated antibody-peptide conjugate combining GLP-1 agonism with GIPR antagonism, designed for monthly or less frequent dosing. Phase 3 readout expected late 2026, BLA filing late 2026 to early 2027.