Accelerating GLP-1 Drug Development: How Metsera, Certara & Altasciences Reached Phase 2

Metsera initially engaged Certara for strategic due diligence and candidate evaluation support.

As development accelerated, the collaboration expanded into a broader partnership spanning integrated drug development strategy, translational modeling, clinical pharmacology, biosimulation, dose optimization, and cross-functional program leadership.

As programs progressed into IND-enabling and clinical development, Altasciences joined as the integrated clinical execution partner, providing:

• Clinical trial execution
• Bioanalytical services
• Biostatistics
• Clinical operations
• Integrated Phase 1-2 delivery across the U.S. and Canada

Altasciences’ acceleration platform also enabled rapid clinical startup through Canada’s favorable early-phase regulatory environment, alongside real-time formulation and bioanalytical capabilities supporting accelerated Phase 1 development.

Together, Certara and Altasciences established a uniquely integrated development model, combining strategic drug development expertise, advanced biosimulation, and coordinated clinical execution across preclinical, translational, and clinical development activities.

Unlike traditional development models, where strategy and operational execution occur separately, Certara and Altasciences operated as a unified extension of Metsera’s organization.

The teams integrated scientific strategy, quantitative modeling, operational execution, and real-time data-informed decisions across the development lifecycle.

This enabled:

• Faster study startup through parallel preclinical and clinical planning, and integrated toxicology and clinical oversight
• Faster study execution, facilitated by real-time decision-making and continuous data visibility
• Faster reporting through coordinated PK analysis and CSR delivery
• Faster decision making through integrated MIDD frameworks that helped optimize study design and dosing strategies before costly downstream decisions were made

Altasciences further streamlined execution through:

• Rapid assay development and validation
• Parallel regulatory preparation
• Shared GLP-1 study templates
• Seamless transition from preclinical to human-ready assays

The result was faster execution without sacrificing participant safety, scientific rigor or data quality.

A major differentiator of the collaboration was the way Model-Informed Drug Development (MIDD) principles were embedded throughout the program lifecycle.

Rather than treating modeling as a standalone scientific activity, Certara integrated quantitative frameworks directly into strategic development decisions, using approaches including:

• PK/PD modeling
• PBPK and QSP modeling
• Model-based meta-analysis (MBMA)

Mechanistic virtual twin simulation

Together, the teams evaluated critical translational questions related to:

• Weight loss
• Safety and tolerability
• Dose optimization
• Exposure-response relationships

By applying multiple modeling approaches, the team improved confidence in development decisions while accelerating progression toward proof-of-concept milestones.

The approach also aligned with growing regulatory support for model-informed development strategies and adaptive trial design frameworks.

For one oral GLP-1 receptor agonist program, the partnership achieved approximately 15.5 months from toxicology initiation to topline clinical data, including:

• IND-enabling studies
• CTA approval
• SAD/MAD execution
• Topline safety and pharmacodynamic results

For an injectable GLP-1 program, the teams achieved approximately 18.5 months from toxicology initiation to 4-week clinical topline data, while simultaneously advancing chronic toxicology studies in parallel.

In a second injectable GLP-1 program, the collaboration enabled progression from First-in-Human initiation to Phase 2a 12-week readout in approximately nine months, through overlapping SAD/MAD cohorts, rapid dose escalation, coordinated safety oversight, and accelerated data analysis.

Over approximately two years, the partnership expanded from support for a single compound into more than 30 integrated engagements spanning six additional oral and injectable GLP-1 assets.

The Metsera collaboration demonstrated how integrating strategic drug development, advanced biosimulation, and coordinated clinical execution can help sponsors:

• Reduce development risk
• Improve study design and decision-making
• Accelerate timelines to proof of concept
• Reduce operational friction
• Build confidence with investors and external stakeholders

The collaboration also highlighted the value of integrating strategic development and execution expertise early in development, when the opportunity to influence timelines, study design, and overall program success is greatest.

By combining Certara’s MIDD expertise with Altasciences’ acceleration platform, the partnership created a scalable framework for faster, smarter early drug development.