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Trial · Interventional

RecruitingPhase 1Registry data

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

NCTNCT07768813 (opens ClinicalTrials.gov in a new tab)Other id1404-0145Other idU1111-1337-6323Other id2026-526307-30-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 1
Enrollment
44 participants (estimated)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
2 Sept 2026
Primary completion
8 Dec 2026 (estimated)
Completion
22 Dec 2026 (estimated)
First posted
17 Aug 2026
Last update posted
9 Sept 2026
Conditions
Healthy · Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027
  1. Ph 1

    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

    NCT07768813

    2 Sept 2026 to est. 22 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Survodutide formulation ACombination product
  • Survodutide formulation B2Drug

Arms2

  • Experimental

    BI 456906 formulation A (Reference) then BI 456906 formulation B2 (Test)

    Subcutaneous administration of formulation A (Reference) then formulation B2 (Test)

  • Experimental

    BI 456906 formulation B2 (Test) then BI 456906 formulation A (Reference)

    Subcutaneous administration of formulation B2 (Test) then formulation A (Reference)

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 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)

    Time frame · Up to Day 22

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame · Up to Day 22

  3. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame · Up to Day 22

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: 1. Male or female trial participant who is healthy or otherwise healthy with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests 2. Age of 18 to 55 years (inclusive) 3. Body mass index (BMI) of 22.0 to 39.9 kg/m\^2 (inclusive) 4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial 5. Further inclusion criteria apply. Exclusion criteria: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 bpm 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Further exclusion criteria apply.

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