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Compares treatment options for Obesity
Official title A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
ClinicalTrials.gov ID: NCT05202353
What this study is testing
What is BI 456906?
BI 456906 is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for obesity.
Also referred to as survodutide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open to adults with obesity. People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male or female people according to the assessment of the investigator, as based on a complete medical history including a physical...
- Age of 18 to 65 years (inclusive)
- Body mass index (BMI) of ≥ 30 and ≤ 40 kg/m2 and body weight ≥70 kg and ≤150 kg
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- Women of childbearing potential (WOCBP) must be willing and able to use two forms of effective contraception where at least one form is a highly...
You likely can't join if
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Resting heart rate \> 100 beats per minute (bpm) and/or systolic blood pressure ≥ 160 millimetre of mercury (mmHg) and/or diastolic blood pressure...
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. people with the following abnormal...
- Low-density lipoprotein (LDL) \> 160 mg/dL (4.15 mmol/L)
- total cholesterol \>240 mg/dL (6.22 mmol/L)
- triglyceride \>200 mg/dL (2.26 mmol/L)
See the full eligibility criteria
- Healthy male or female people 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...
- Age of 18 to 65 years (inclusive)
- Body mass index (BMI) of ≥ 30 and ≤ 40 kg/m2 and body weight ≥70 kg and ≤150 kg
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- Women of childbearing potential (WOCBP) must be willing and able to use two forms of effective contraception where at least one form is a highly effective method of birth control per International Council for...
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Resting heart rate \> 100 beats per minute (bpm) and/or systolic blood pressure ≥ 160 millimetre of mercury (mmHg) and/or diastolic blood pressure ≥95 mmHg at screening.
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. people with the following abnormal values are not eligible for the trial participation:
- Low-density lipoprotein (LDL) \> 160 mg/dL (4.15 mmol/L)
- total cholesterol \>240 mg/dL (6.22 mmol/L)
- triglyceride \>200 mg/dL (2.26 mmol/L)
- blood glucose \> 126 mg/dl (\>7 mmol/L) fasting and/or glycated haemoglobin (HbA1c) \>6.5% (\>48 mmol/mol)
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator. people with type 1 and type 2 diabetes mellitus are not eligible for the trial
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
- Diseases of the central nervous system (including but not limited to any kind of seizures), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1 Further criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.