BridgeMD
New treatment option for Obesity &Amp; Overweight
Official title UBT251 Injection Phase II Clinical Study (CKD)
ClinicalTrials.gov ID: NCT07134335
What this study is testing
What is UBT251?
UBT251 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity & overweight.
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 multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of UBT251 injection in obese/overweight chronic kidney disease (CKD) population
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 75
You may be able to join if
- Age 18\~75 years old (including border value), BMI \>=24 kg/m\^2, gender is not limited.
- Subject estimated glomerular filtration rate (eGFR): \>=45 and \< 90 mL/min/1.73m\^2 (calculated using the CKD-EPI formula).
- people 300 mg/g \<= UACR \<= 5000 mg/g 3 months or more prior to screening; At least 2 measurements (not on the same day) within 4 weeks of the...
- If treated with SGLT2i, angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists...
- Volunteer to participate in the study and sign the ICF.
You likely can't join if
- History or evidence of any of the following diseases: 1) Diagnosis of type 1 diabetes or other special type diabetes. 2) Presence of non-recovered...
- Medication history within 3 months prior to randomization that meets any of the following conditions: 1) Receive dipeptidyl peptidase 4 (DPP-4)...
- Those who have any of the following test abnormalities during screening: 1) Severe anemia (hemoglobin \ = 3 ×upper limit of normal [ULN], or serum...
- Body weight change of more than 5% within 6 weeks prior to screening.
- Those who have had or plan to undergo bariatric surgery during the trial.
- Those with a history of alcohol and drug abuse.
See the full eligibility criteria
- Age 18\~75 years old (including border value), BMI \>=24 kg/m\^2, gender is not limited.
- Subject estimated glomerular filtration rate (eGFR): \>=45 and \< 90 mL/min/1.73m\^2 (calculated using the CKD-EPI formula).
- people 300 mg/g \<= UACR \<= 5000 mg/g 3 months or more prior to screening; At least 2 measurements (not on the same day) within 4 weeks of the screening period, and each measurement must meet this criterion.
- If treated with SGLT2i, angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs) before screening, a stable dose of \>=4 weeks is required...
- Volunteer to participate in the study and sign the ICF.
- Female of childbearing potential or male people with partners of childbearing potential agree to use effective contraception from the start of study treatment until 3 months after the end of the last dose.
- History or evidence of any of the following diseases: 1) Diagnosis of type 1 diabetes or other special type diabetes. 2) Presence of non-recovered acute kidney injury (AKI) at screening. 3) Previous or current...
- Medication history within 3 months prior to randomization that meets any of the following conditions: 1) Receive dipeptidyl peptidase 4 (DPP-4) inhibitors, amylin analogues, glucagon-like peptide-1 (GLP-1) analogues...
- Those who have any of the following test abnormalities during screening: 1) Severe anemia (hemoglobin \ = 3 ×upper limit of normal [ULN], or serum total bilirubin [TBIL] \>= 1.5 × ULN); 3) Serum albumin \ 5.5 mmol/L; 5)...
- Body weight change of more than 5% within 6 weeks prior to screening.
- Those who have had or plan to undergo bariatric surgery during the trial.
- Those with a history of alcohol and drug abuse.
- Those who are allergic to the study drug or its excipients.
- Those who have participated in other clinical trials within 30 days before screening (except for screening only but not medicated or non-treatment studies) or within 5 half-lives of using investigational drugs...
- Subject is receiving dialysis/kidney transplantation or plans to undergo dialysis/kidney transplantation during the study.
- Pregnant or lactating women.
- Other conditions that the investigator considers unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. 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.