Alveus Doses First Patient in Phase 2 PRESERVE Trial of ALV-100 for Weight Maintenance After Semaglutide
核心洞察
Alveus Therapeutics (搜索) has dosed the first patient in the Phase 2 PRESERVE trial of ALV-100 (搜索), a bifunctional GIPR (搜索) antagonist and GLP-1R (搜索) agonist fusion protein.
The randomized, double-blind, placebo-controlled study will enroll about 220 adults who lost at least 10% of body weight and stabilized on semaglutide.
Participants will receive one of four ALV-100 (搜索) dose regimens or placebo for 24 weeks, with percentage change in body weight as the primary endpoint.
Alveus Therapeutics (搜索) Inc. has initiated its Phase 2 PRESERVE trial and dosed the first patient with ALV-100 (搜索), its lead investigational therapy, in adults with obesity (搜索) or overweight who have achieved and stabilized weight loss with semaglutide and are transitioning to long-term weight management. The Boston- and Copenhagen-based clinical-stage biotechnology company announced the milestone on Sept. 14, 2026.
ALV-100 (搜索) is a bifunctional glucose-dependent insulinotropic polypeptide receptor (GIPR (搜索)) antagonist / glucagon-like peptide-1 receptor (GLP-1R (搜索)) agonist fusion protein designed to address long-term weight management and tolerability in adults with obesity (搜索). The company positions the program against one of the most important unmet needs in obesity care: sustaining weight loss over time.
"The first generation of obesity (搜索) therapies has transformed what's possible by helping patients achieve meaningful weight loss," said Jacob Jeppesen, PhD, Chief Scientific Officer at Alveus. "The next challenge is helping patients sustain those outcomes over years, not months. We designed ALV-100 (搜索) around that unmet need. PRESERVE is an important step toward understanding whether our differentiated GIP receptor antagonist and GLP-1 receptor agonist approach can provide patients with a durable, well-tolerated option for long-term weight management."
A Maintenance Trial, Not an Induction Study
Unlike traditional induction studies focused on achieving weight loss, PRESERVE is specifically designed to evaluate long-term weight management following successful treatment with a GLP-1 therapy. The randomized, double-blind, placebo-controlled Phase 2 trial will enroll approximately 220 adults with obesity (搜索) or overweight who have lost at least 10% of body weight and reached a stable weight on semaglutide.
Participants across multiple U.S. sites will be randomized to one of four ALV-100 (搜索) dose regimens or placebo for 24 weeks, with the primary endpoint measuring percentage change in body weight from randomization. The design is explicitly a maintenance study rather than an induction trial, making it a direct test of whether ALV-100 can serve as a lower-burden maintenance therapy after initial GLP-1 treatment.
Differentiating the GIP Mechanism
ALV-100 (搜索) combines GLP-1 receptor agonism with GIPR (搜索) antagonism, a mechanism Alveus believes could support durable weight control with less frequent treatment. The GIPR antagonist component differentiates ALV-100 from semaglutide and from Eli Lilly's tirzepatide, which activates rather than inhibits GIPR. PRESERVE is not designed to compare the two GIP strategies directly; instead, it will test whether monthly ALV-100 can maintain weight loss after patients discontinue semaglutide.
Weight regain after withdrawal of GLP-1-based therapy has become an increasingly important development target as obesity (搜索) treatment moves toward long-term maintenance strategies. PRESERVE is unusual in specifically enrolling patients who have already achieved and stabilized substantial weight loss on semaglutide.
Pipeline, Licensing and Financing
A Phase Ib dose-escalation study of ALV-100 (搜索) in overweight and obese participants with or without type 2 diabetes (搜索) is currently recruiting separately. Alveus acquired global rights outside greater China to ALV-100 from Gmax Biopharm International Ltd (搜索) in 2024, and closed a USD 197 million Series A financing in February 2026 with participation from Novo Holdings, Jeito Capital, New Rhein Healthcare Investors, Andera Partners, Omega Funds, and Sanofi Capital, among others. The company said it targets a Phase III-ready program within 18 to 24 months of that closing.
Alveus describes itself as developing next-generation medicines for obesity (搜索) and metabolic disease with a mission to make weight loss last, advancing a proprietary pipeline focused on durability, tolerability, body composition, and simplicity of obesity treatment. All programs beyond its lead asset have been discovered and developed in-house.