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Official title A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
ClinicalTrials.gov ID: NCT07407348
What this study is testing
What is Formulation A?
Formulation A is an investigational medicine, being studied as a potential treatment for healthy.
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
- The primary objective of this trial is to assess bioequivalence of two formulations of survodutide (formulation A and formulation B6) after multiple-dose treatment in male and female trial participants living with overweight or obesity.
- Phase 1: an early, usually small safety study
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 trial participant 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 27.0 to 39.9 Kg/ m\^2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- For women of child-bearing potential (WOCBP) trial participants: Woman of childbearing potential (WOCBP) trial participants who meet any of the...
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
- Repeated measurement of systolic Blood pressure (BP) outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 100 mmHg, or PR...
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Diseases of the Central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or...
See the full eligibility criteria
- 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))...
- Age of 18 to 65 years (inclusive)
- Body Mass Index (BMI) of 27.0 to 39.9 Kg/ m\^2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- For women of child-bearing potential (WOCBP) trial participants: Woman of childbearing potential (WOCBP) trial participants who meet any of the following criteria for a highly effective contraception from at least 28...
- 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 or...
- Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants). In case of oral contraception, a barrier method should be used in addition or advised to change to non-oral...
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- Complete abstinence (refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) is considered a highly effective method of contraception only if it is in line with the...
- Bilateral tubal ligation/occlusion is considered a highly effective method of contraception, provided that the procedure has not been reversed or failed.
- Surgically sterilised (including hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause
- Any finding in the medical examination (including BP, PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic Blood pressure (BP) outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 100 mmHg, or PR outside the range of 50 to 100 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Diseases of the Central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections within the 4 weeks prior to screening Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, United Kingdom
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Nottingham, United Kingdom. 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.