New obesity pill enters human safety testing
NCT ID NCT06982131
First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 9 times
Summary
This early-stage study tests an experimental oral drug called RO7795081 in 40 healthy overweight or obese adults. The main goals are to check safety and how the drug interacts with common statins (rosuvastatin and pitavastatin). Participants will receive the drug or a placebo in multiple phases, and researchers will monitor side effects and drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RO7795081 (also called CT-996 or RG6652)
- What this could lead to
- If successful, this could lead to a new oral medication for weight management that may be used alongside statins.
- What could go wrong
- This is a very early Phase 1 safety study with only 40 participants, so it may not show effectiveness or could reveal safety issues. Results may not apply to the general population.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
Anyone
- Healthy volunteers
-
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: * Healthy participants with no clinically relevant findings on physical examination at screening and at baseline (including detailed medical and surgical history, vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis); with no suspicion of cognitive impairment or dementia as judged by the Investigator; who are not under judicial supervision, guardianship, or curatorship. * 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 between screening and Day -1 of Period 1 as per measured weight * Agreement to adhere to the contraception requirements Exclusion Criteria: * 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, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator * History or presence of any clinically significant cardiovascular, broncho-pulmonary, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric, or metabolic disorders, allergic diseases, hypofertility, cancer, or cirrhosis * 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 CNS infections (e.g., meningitis) * History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma
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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.
Contacts and locations
Locations
-
ICON Plc (LPRA) - Netherlands
Groningen, 9728 NZ, Netherlands
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