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Trial · Interventional

CompletedPhase 1Registry data

A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector

NCTNCT07413913 (opens ClinicalTrials.gov in a new tab)Other id1404-0015Other idU1111-1314-3577Other id2024-519614-30-00
Open at ClinicalTrials.govAsk about this trial

Overview

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

Germany

Start
3 Mar 2026
Primary completion
28 May 2026
Completion
11 Jun 2026
First posted
17 Feb 2026
Last update posted
15 Jun 2026
Conditions
Healthy · Obesity

Timeline

1 trial · 1 completed

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

    A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector

    NCT07413913

    3 Mar 2026 to 11 Jun 2026

Registry summary

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

The goal of this study is to find out whether different formulations of survodutide given by different delivery methods is taken up in the body in a similar way. Participants visit the study site regularly. During study visits, the doctors collect information about participants' health. To assess the study endpoints, participants regularly have blood samples taken.

Interventions

  • Survodutide formulation ACombination product
  • Survodutide formulation B2Combination product

Arms2

  • Experimental

    Survodutide formulation A then Survodutide formulation B2

    Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment

  • Experimental

    Survodutide formulation B2 then Survodutide formulation A

    Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment

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.

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 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/m2 (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 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 millimetre of mercury (mmHg), diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 beats per minute (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 Further exclusion criteria apply.

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