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Trial · Interventional

CompletedPhase 1Registry data

A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body

NCTNCT07221591 (opens ClinicalTrials.gov in a new tab)Other id1404-0103Other id2025-522325-35-00Other idU1111-1322-4700Other id2025
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Overview

Status
Completed
Phase
Phase 1
Enrollment
100 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
5 Nov 2025
Primary completion
28 Jul 2026
Completion
28 Jul 2026
First posted
28 Oct 2025
Last update posted
4 Aug 2026
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 1

    A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body

    NCT07221591

    5 Nov 2025 to 28 Jul 2026

Registry summary

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

This study is open to healthy people between 18 and 65 years of age. People can join the study if they have a body mass index between 27 and 39.9 kg/m2. The purpose of this study is to test a new formulation of a medicine called survodutide. Survodutide is being developed to help people with obesity and people with liver conditions. When a new formulation is developed, it is important to understand how it is taken up by the body. Participants are divided into 2 groups by chance. One group gets the reference formulation of survodutide (formulation A). The other group gets the new formulation of survodutide (formulation B2). Participants in both groups inject survodutide under their skin once a week for about 6 and a half months. Participants are in the study for about 7 months. During this time, they visit the study site 15 times. For one of the visits, participants stay overnight for 3 nights at the study site. The site staff takes blood samples to measure how much survodutide is in the blood. They also check participants' health and take note of any unwanted effects.

Interventions

  • survodutideCombination product

Arms2

  • Active comparator

    survodutide formulation A (reference treatment)

  • Experimental

    survodutide formulation B2 (test treatment)

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

    Time frame · up to 232 days

  2. Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

    Time frame · up to 232 days

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.

Completed trials do not always post results.

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 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: * Healthy male or female trial participant 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 * Age of 18 to 65 years (inclusive) * Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive) * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply. Exclusion criteria: * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 150 mmHg, diastolic blood pressure outside the range of 50 to 100 mmHg, or pulse rate outside the range of 50 to 100 bpm * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease assessed as clinically relevant by the investigator. Presence of hypertension, hypothyroidism, hyperuricaemia and hypercholesterolaemia are acceptable if well-controlled according to the investigator's judgement. Further exclusion criteria apply.

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