Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in… (NCT07754045) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults
202 participantsStarted 2027-02-15
Plain-language summary
This is a phase 2 randomized, double-blind, placebo-controlled, multi-center study evaluating the efficacy and safety of LUM-201 plus Semaglutide versus Semaglutide plus placebo in obese adults with body mass index between 30 and 45 kg/m\^2, between the ages of 60 and 85 years that have mild functional impairment.
Who can participate
Age range
60 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be willing to provide written informed consent to participate in this study.
* Males or females, aged ≥ 60 to \< 85 years.
* Have a BMI ≥ 30 kg/m2.
* SPPB score at the screening visit ≥ 7 to ≤ 9.
* Have a history of ≥ 1 self-reported unsuccessful dietary effort to lose weight.
* Female participants must be postmenopausal, confirmed by an follicle stimulating hormone (FSH) level ≥ 25 IU/L.
* Male participants must be able to comply with contraception requirements.
* Must agree to refrain from any reconstructive and/or cosmetic surgery and/or non-invasive cosmetic procedure that may affect body weight during the study such as mammoplasty, lipoplasty, non-invasive adipose and/or cellulite treatment devices.
* Must refrain from scheduling any elective surgery and/or other invasive or non-invasive procedures during the study unless medically warranted.
Exclusion Criteria:
* Have Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM).
* Have laboratory evidence diagnostic of diabetes mellitus during screening.
* Have history of diabetic ketoacidosis or hyperosmolar state/coma within 6 months prior to screening.
* Have a history of severe hypoglycemia.
* Have a BMI \> 45 kg/m2 or weight \> 159 kg (350 lbs.).
* Have a self-reported change in body weight \> 5 kg (11 lbs.) within 3 months prior to screening.
* Have received prior exposure to a GLP-1 receptor agonist (including dual GLP-1/ GIP receptor agonists\]) within 180 days before screening, an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with Short Physical Performance Battery (SPPB) score ≤ 7 at Week 26.