A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity

March 12, 2026 updated by: Boehringer Ingelheim

A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial With Moxifloxacin as Positive Control to Evaluate the Effects of Multiple Subcutaneous Doses of BI 456906 in a Titration Scheme on Cardiac Safety Parameters in (Otherwise) Healthy Male and Female Subjects With Overweight/Obesity

This study is open to adults between 18 and 55 years of age with overweight or obesity. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) has an effect on cardiac safety. When a new medicine is developed, it is important to check whether it affects the heart. Moxifloxacin is a medicine that is known to change the heart rhythm. In this study, moxifloxacin is used as a so-called positive control.

Participants are put into 3 groups by chance. There is a different treatment schedule for each of the groups. All participants start with one placebo injection under their skin. The next day, depending on the group, participants take either moxifloxacin or placebo as a tablet. Then, for about 30 weeks, participants receive survodutide or placebo as an injection under their skin once a week. After this, they take again a single dose of moxifloxacin or placebo.

Participants are in the study for up to 9 months. During this time, they visit the study site regularly. For 2 of the visits, participants stay at the study site for 2 nights. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the study staff regularly performs ECG tests. The doctors also regularly check participants' health and take note of any unwanted effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Mannheim, Germany, 68167
        • CRS Clinical Research Services Mannheim GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Otherwise healthy male or female subjects 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 27.0 to 39.9 kg/m2 (inclusive) and body weight > 70 kg
  4. Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

  5. Female subjects who meet any of the following criteria for a highly effective contraception from at least 7 days before the first administration of trial medication until 28 days after trial completion:

    • Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal). In case of oral contraception a barrier method should be used in addition.
    • Use of progestogen-only hormonal contraception that inhibits ovulation (oral, injectable or implantable). In case of oral contraception a barrier method should be used in addition.
    • Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
    • Sexually abstinent
    • A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
    • Surgically sterilised (including hysterectomy)
    • Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle Stimulating Hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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 blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)

  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and, in particular:

    • Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%
    • Aspartate aminotransferase (AST) above ULN + 20%
    • Gamma glutamyltransferase (GGT) above ULN + 20%
    • Lipase or amylase above ULN + 20%
    • Bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome)
    • eGFR < 60 mL/min/1.73 m²
  4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  6. History of either chronic or acute pancreatitis
  7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: R1 then R3 then T then R
Arm A: BI 456906-placebo (reference treatment 1 (R1)) then moxifloxacin-placebo (reference treatment 3 (R3)) then BI 456906 (Test Treatment (T)) then moxifloxacin-placebo (R3)
Drug: Placebo to moxifloxacin
Film-coated tablet
Combination product: BI 456906
Solution for injection, pre-filled syringe
Other Names:
  • survodutide
Combination product: Placebo to BI 456906
Solution for injection, pre-filled syringe
Other Names:
  • BI 456906-placebo
Placebo Comparator: Arm B: R1 then R2 then R1 then R3
Arm B: BI 456906-placebo (R1) then moxifloxacin (Reference Treatment 2 (R2)) then BI 456906-placebo (R1) then moxifloxacin-placebo (R3)
Drug: Moxifloxacin
Film-coated tablet
Drug: Placebo to moxifloxacin
Film-coated tablet
Combination product: Placebo to BI 456906
Solution for injection, pre-filled syringe
Other Names:
  • BI 456906-placebo
Placebo Comparator: Arm C: R1 then R3 then R1 then R2
Arm C: BI 456906-placebo (R1) then moxifloxacin-placebo (R3) then BI 456906-placebo (R1) then moxifloxacin (R2)
Drug: Moxifloxacin
Film-coated tablet
Drug: Placebo to moxifloxacin
Film-coated tablet
Combination product: Placebo to BI 456906
Solution for injection, pre-filled syringe
Other Names:
  • BI 456906-placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time-matched QTcI change from baseline (ΔQTcI) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo
Time Frame: up to 30 weeks.
QTcI is the QT interval (electrocardiogram interval from the start of the QRS complex (combination of the Q wave, R wave and S wave) to the end of the T wave) individually corrected for heart rate.
up to 30 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The QTcI change from baseline (ΔQTcI) collected at the same time points as the moxifloxacin plasma concentrations up to 12 hours after drug administration of a single dose of moxifloxacin or moxifloxacin-placebo
Time Frame: up to 12 hours.
up to 12 hours.
The time-matched heart rate change from baseline (ΔHR) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo
Time Frame: up to 30 weeks.
up to 30 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1404-0011
  • 2023-506375-10-00 (Registry Identifier: CTIS)
  • U1111-1295-4369 (Other Identifier: WHO Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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