Survodutide formulation A / Obesity / Survodutide formulation B2 · Phase 1 Trial

A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered Phase 1 bioequivalence study comparing two formulations of survodutide (pre-filled syringe vs. vial) on the basis of plasma pharmacokinetics. No efficacy or safety results are reported in this registry record, and the study has not yet begun recruitment.

What was studied

Phase 1, Interventional, Randomized, Crossover, Open label, Treatment purpose. Healthy, Obesity; age from 18 Years; to 55 Years; accepts healthy volunteers. Intervention: BI 456906 formulation A (Reference) then BI 456906 formulat…; BI 456906 formulation B2 (Test) then BI 456906 formulation…. Compared with: The two formulations are compared against each other for bioequivalence. n = 44. 1 site: Germany.

Key findings

Safety

Bioequivalence endpoints are pharmacokinetic surrogates; clinical benefit or safety outcomes are not described.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 1 bioequivalence study registration with no results posted; it describes a planned pharmacokinetic comparison in healthy volunteers and those with overweight/obesity.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) (assessed at Up to Day 22); Maximum measured concentration of the analyte in plasma (Cmax) (assessed at Up to Day 22); Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (assessed at Up to Day 22)

DesignPhase 1, Interventional, Randomized, Crossover, Open label, Treatment purpose

PopulationHealthy, Obesity; age from 18 Years; to 55 Years; accepts healthy volunteers

Sample size44

InterventionBI 456906 formulation A (Reference) then BI 456906 formulat…; BI 456906 formulation B2 (Test) then BI 456906 formulation…

ComparatorThe two formulations are compared against each other for bioequivalence

Setting1 site: Germany

Reported figures

Quoted from the source exactly as published.

Planned enrollment44

PhasePhase 1

Primary outcome measure 1AUC0-tz (Area under concentration-time curve from 0 to last quantifiable point), up to Day 22

Primary outcome measure 2Cmax (Maximum measured plasma concentration), up to Day 22

Primary outcome measure 3AUC0-∞ (Area under concentration-time curve from 0 extrapolated to infinity), up to Day 22

Caveats

This is a registry record only; no results are reported or available.
Study has not yet begun recruitment (status: NOT_YET_RECRUITING).
Randomization method, blinding strategy, and detailed eligibility criteria are not specified in the registry record.
Bioequivalence endpoints are pharmacokinetic surrogates; clinical benefit or safety outcomes are not described.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional design with two formulations; bioequivalence objective is well-defined.

Directness

moderate

Pharmacokinetic endpoints (AUC, Cmax) are surrogate measures; clinical efficacy not addressed.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study design details (randomization, blinding) not specified in registry record.

Sample adequacy

limited

Planned enrollment of 44 participants is typical for Phase 1 PK studies but modest.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07768813). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 44 participants (ESTIMATED). Conditions: Healthy, Obesity. Interventions: COMBINATION_PRODUCT: Survodutide formulation A; DRUG: Survodutide formulation B2. Primary outcome measures: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) , Up to Day 22; Maximum measured concentration of the analyte in plasma (Cmax) , Up to Day 22; Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) , Up to Day 22. Brief summary: The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product \[formulation A\]) and in a vial (test product \[formulation B2\]) in male and female trial participants who are healthy or otherwise healthy with overweight/obesity, following subcutaneous administration.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Survodutide formulation AObesityNCT07768813Survodutide formulation B2HealthyBoehringer Ingelheim