Clinical trial for Overweight
Official title A Research Study Looking Into How UBT251 Works With Birth Control Tablets and Emptying of the Stomach in Women With Excess Body Weight Not Able to Become Pregnant
ClinicalTrials.gov ID: NCT07710729
What this study is testing
What is UBT251?
This is an investigational medicine being studied to see if it helps with weight in people who are overweight or have obesity.
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 study aims to find out if UBT251 is safe and works when taken with birth‑control tablets and a stomach‑emptying procedure in women with excess weight who cannot get pregnant.
- Who it's for
- Women who are overweight or obese and are unable to become pregnant.
- What's involved
- Participants will take the study drug UBT251, continue using birth‑control pills, undergo a stomach‑emptying procedure, and have regular check‑ups and tests to monitor safety and effectiveness.
- 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, women only. Healthy volunteers may be eligible.
You may be able to join if
- Female (sex assigned at birth) of NCBP.
- Age 18-65 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 27.0-39.9 kg/m\^2 (both inclusive) at screening.
- Body weight \>= 60.0 kg.
- Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital...
You likely can't join if
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Treatment with any compound containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG)...
- Any contraindications for the use of the oral contraception used in the study according to the PORTIA Product Information.
- Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the...
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450...
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or...
See the full eligibility criteria
- Female (sex assigned at birth) of NCBP.
- Age 18-65 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 27.0-39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Body weight \>= 60.0 kg.
- Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during...
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Treatment with any compound containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.
- Any contraindications for the use of the oral contraception used in the study according to the PORTIA Product Information.
- Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study.
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
- History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
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, but 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 female, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.