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Healthy volunteers help test two forms of experimental drug

NCT ID NCT07071974

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed phase 1 trial enrolled 16 healthy adults to compare two formulations of the drug BI 456906 (Survodutide). Participants received a single injection of each version in random order. Researchers measured how much drug got into the blood and how quickly, to see if the formulations behave similarly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Survodutide (BI 456906)
What this could lead to
If successful, this could help select the better formulation for future studies, potentially leading to a more effective or convenient treatment.
What could go wrong
This is a very early, small study in healthy people, not patients. It only measures drug levels in the blood, not whether the drug works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Jul 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Trial participants will only be included in the trial if they meet the following criteria: 1. 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 2. Age of 18 to 55 years (inclusive) 3. Body Mass Index (BMI) of 18.5 to 29.9 kg/m (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP (Harmonized Guideline for Good Clinical Practice) and local legislation prior to admission to the trial Further inclusion criteria apply. Exclusion Criteria : Participants will not be allowed to participate, if any of the following general criteria apply: 1. Any finding in the medical examination (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 and, in particular: * Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20% * Aspartate aminotransferase (AST) above Upper limit of normal (ULN) + 20% * Gamma Glutamil Transferase (GGT) above Upper limit of normal (ULN) + 20% * Lipase or amylase above Upper limit of normal (ULN) + 20% * Bilirubin above 1.2x Upper limit of normal (ULN) (except for cases of Gilbert's Syndrome) * Estimated Glomerular Filtration Rate Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73 m² 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CRS Clinical Research Services Berlin GmbH

    Berlin, 13627, Germany

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