Can a new injection help tackle obesity? a trial investigates
NCT ID NCT07754474
First seen Aug 10, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This early-stage trial is testing an investigational drug called BI 3034701 in people with overweight or obesity who also have at least one weight-related health condition. The main goal is to see how safe and tolerable the drug is when given by injection, and to understand how it moves through the body. Participants will receive either the drug or a placebo, and the study will compare different ways of adjusting the dose over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 3034701, an investigational drug given by injection, compared to placebo
- What this could lead to
- If successful, this could lead to a new treatment option for weight management in people with overweight or obesity and related health issues.
- What could go wrong
- This is an early Phase 1 trial with a small number of participants, so safety and effectiveness are not yet established. The drug may cause side effects or may not work as hoped.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- 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
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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. Male or female trial participant, overweight/obese with one weight related complication but otherwise healthy 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 74 years (inclusive) 3. Body mass index (BMI) of 27.0 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 5. Further inclusion criteria apply. Exclusion criteria: 1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator, unless confirming the weight related complication 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm, unless arterial hypertension is the weight related complication in the context of this trial 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and may interfere with trial participation or interpretation of the results, other than abnormalities attributable to the permitted weight-related complications 4. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI)) at screening or trial participants requiring dialysis 5. Further exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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hVIVO Mannheim
Mannheim, 68167, Germany
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