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Study on the Efficacy and Safety of Initial Combination of Finerenone and Semaglutide in Non-Diabetic Adult Patients With Obesity Complicated by Chronic Kidney Disease With Albuminuria
Plain-language guide to NCT07849348: not phased randomized trial of Semaglutide, 266 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07849348
- Phase
- not phased
- Status
- not yet recruiting
- Start
- 2026-09
- Completion (planned or actual)
- 2027-02
- Participants
- 266 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Obesity; Chronic Kidney Disease; Albuminuria
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Semaglutide.
Approximately 266 participants will be randomized in a 1:1 ratio.
The treatment period will last 24 weeks, followed by a 4-week off-treatment follow-up period.
It had two arms (groups): Finerenone combined with semaglutide injection (experimental) and Finerenone placebo combined with semaglutide injection for intervention (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
Eligible participants will be randomized 1:1 to semaglutide plus finerenone or semaglutide plus matching finerenone placebo.
Randomization will be stratified by baseline UACR category and BMI category.
The double-blind treatment period is 24 weeks, followed by 4 weeks off treatment.
The primary objective is to compare change from baseline in UACR at Week 24.
Who Took Part
266 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 1\. Age \>=18 years at the time of signing the informed consent form, without gender restriction;. 2\. Meet one of the following definitions of excess adiposity at screening:. BMI \>=28 kg/m\^2 and waist-to-height ratio \>=0.5;. 3\. Clinically diagnosed with chronic kidney disease (CKD), and meet all of the following:.
The full record lists 9 inclusion and 21 exclusion criteria; among the exclusions: 1\. known allergy to the study drug (active ingredients or excipients) or similar drugs; 4\. patients with chronic kidney disease (ckd) requiring hormonal or immunosuppressant therapy within 6 months prior to screening; 5\. mean blood pressure \> 160/100 mmhg or mean systolic blood pressure \< 90 mmhg at screening.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Semaglutide group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2026-09 with completion listed for 2027-02.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Week 24 (time frame: Baseline to Week 24).
It also tracked 15 secondary outcomes, for example Proportion of Participants With Regression of Albuminuria Category, Change From Baseline in Creatinine-based Estimated Glomerular Filtration Rate (Cr-eGFR), Change From Baseline in Cystatin C-based Estimated Glomerular Filtration Rate (Cys-C-eGFR), Estimated Glomerular Filtration Rate Slope Through Week 24, Change From Baseline in Body Weight and Change From Baseline in Waist Circumference.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Semaglutide in 266 people.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.