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Tests treatment safety and results for Overweight
Official title A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants
ClinicalTrials.gov ID: NCT06982131
What this study is testing
What is RO7795081?
RO7795081 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for overweight.
Also referred to as CT-996, RG6652.
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 is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered RO7795081 and the effect of a steady-state dose of orally administered RO7795081 on the pharmacokinetics of pitavastatin and rosuvastatin in otherwise healthy, overweight or obese adult participants.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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 participants with no clinically relevant findings on physical examination at screening and at baseline (including detailed medical and...
- Body Mass Index (BMI) ≥27.0 kg/m\^2 at screening and on Day -1 of Period 1
- Stable body weight (defined as \<5% gain or loss) in the 2 months prior to screening as per verbal report by the participant and for the period...
- Agreement to adhere to the contraception requirements
You likely can't join if
- Pregnant, breastfeeding, or intending to become pregnant during the study
- Any condition or disease detected during the medical interview or physical examination that would render the participant unsuitable for the study...
- History or presence of any clinically significant cardiovascular, broncho-pulmonary, hepatic, renal, gastrointestinal, endocrinological...
- History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs
- History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or...
- History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Groningen, 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.