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survodutide glp 1 agonist rct 2025-02-10 ClinicalTrials

Survodutide Bioavailability Study Compares Three Formulations in Healthy Adults

A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body

Background

Survodutide (BI 456906) is a novel glucagon/GLP-1 receptor co-agonist currently in development for treating obesity and non-alcoholic steatohepatitis (NASH). Optimizing drug delivery is crucial for maximizing efficacy and patient convenience. This study addresses the knowledge gap in understanding how different formulations of Survodutide affect its uptake and availability in the body.

Study Design

Population
Healthy adult volunteers were studied to assess drug uptake.
Intervention
Survodutide was administered in three different formulations over 22 days.
Comparator
active comparator (three different Survodutide formulations)
Outcome
The primary outcome measured was the relative bioavailability of Survodutide formulations, assessed by AUC0-tz and Cmax.

Results

This Phase 1 trial, while completed, has not yet publicly released its findings as of the current date. The study aimed to determine the relative bioavailability of Survodutide formulations by analyzing plasma concentrations over 22 days to compare how each formulation is absorbed and reaches its peak concentration. Researchers will assess AUC0-tz (Area Under the Curve from time 0 to the last quantifiable data point, representing total drug exposure) and Cmax (Maximum measured concentration, indicating peak drug levels). > Once available, the most important finding will reveal which formulation demonstrates superior bioavailability, potentially leading to more consistent drug levels and improved patient outcomes. The data will quantitatively compare the absorption profiles and peak concentrations across the three formulations, identifying any statistically significant differences.

Why It Matters

Optimizing Survodutide's formulation is critical for its future development as a potential treatment for obesity and NASH. A formulation with improved bioavailability could lead to more effective dosing strategies, potentially requiring lower doses or less frequent administration, and fewer side effects, accelerating its path to market. This foundational pharmacokinetic data will directly inform the selection of the most promising formulation for subsequent larger-scale Phase 2 and Phase 3 clinical trials, moving closer to potential clinical use.


survodutide glp 1 agonist glucagon agonist glp-1r protocol relevant
Source: clinicaltrials:NCT06772532 · Ingested 2026-04-28 · Digest: gemini-2.5-flash