First human test of experimental drug BI 3034701 begins
NCT ID NCT06352437
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called BI 3034701 for the first time in humans. It involved 125 healthy men and people with overweight or obesity to see how safe the drug is and how it moves through the body. Participants received either the drug or a placebo as an injection under the skin. The goal was to gather safety information, not to treat any disease.
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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
-
125 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
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Oct 2025
- Lead sponsor
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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 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: 1. Part A: healthy male 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. Part B: 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 (BP, PR), 12-lead ECG, and clinical laboratory tests. 2. Part A: age of 18 to 55 years (inclusive). Part B: age 18 to 65 years (inclusive). 3. Parts A and B: 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. 4. 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 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-Glutamyl-Transferase (GGT) above ULN + 20% * Lipase or amylase above ULN + 20% * Bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome) * Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m² 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator. 5. 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
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Charité Research Organisation GmbH
Berlin, 10117, Germany
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