Can a new pill help older adults lose weight without losing strength?
NCT ID NCT07754045
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding an experimental oral drug called LUM-201 to the weight-loss medication semaglutide can improve physical function in older adults with obesity. The study enrolls people aged 60 to 85 with a body mass index (BMI) between 30 and 45 who have mild mobility limitations. Participants receive either LUM-201 plus semaglutide or a placebo plus semaglutide for 26 weeks. The main goal is to see if the combination helps preserve or improve physical performance, as measured by a standard mobility test, while also tracking changes in body fat and muscle mass.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LUM-201 (an oral drug) added to oral semaglutide
- What this could lead to
- If successful, this combination could help older adults with obesity lose fat while preserving muscle and improving mobility, potentially reducing disability and falls.
- What could go wrong
- This is an early-phase trial, so results may not hold up in larger studies. Adding LUM-201 could increase side effects or fail to improve physical function beyond semaglutide alone.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 202 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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60 to 84 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * 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, any other anti-obesity medication, glucose-lowering agent (non-GLP-1), or glucose lowering supplements such as berberine, etc. within 90 days before screening. * Have any other condition not listed in this section (for example, hypersensitivity or intolerance) that is a contraindication to GLP-1 receptor agonist or dual GLP-1/GIP receptor agonist. * Have serum calcitonin concentration \> 35 pg/mL at screening. * Have a history of prior or planned surgical treatment for obesity. * Have uncontrolled hypertension with systolic blood pressure (SBP) ≥ 150 mm Hg and/or diastolic blood pressure (DBP) ≥ 95 mm Hg. * Mean QTcF (Fridericia \[QTcF=QT/RR1/3\]) interval \> 450 ms (male) or \> 470 ms (female) on triplicate ECGs. * Have fasting triglyceride \> 500 mg/dL. * Have any of the following within last 6 months prior to screening: NYHA Functional Classification I-IV heart failure, myocardial infarction, angina, coronary artery bypass graft, percutaneous coronary intervention, transient ischemic attack, stroke, or decompensated congestive heart failure. * Have an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2. * Have a known clinically significant gastric emptying abnormality. * Have a history of chronic or acute pancreatitis, or severe gastroesophageal reflux disease and symptomatic cholelithiasis with intact gallbladder. * Have serum lipase and/or amylase above 1.5 × the upper limit of normal (ULN). * Have a history of hepatic disorders including cirrhosis or other hepatic disorder other than metabolic-associated fatty liver disease (MAFLD), or nonalcoholic fatty liver disease. * Have active hepatitis B or C virus at screening. Have known positive history of human immunodeficiency virus. Have an active Coronavirus Disease 2019 at screening. * Have an impaired liver function, defined as screening aspartate aminotransferase (AST) \> 2.5 × ULN, or alanine aminotransferase \> 2.5 × ULN, or total bilirubin level \> 1.2 × ULN (except for cases of known Gilbert's Syndrome). * Alkaline phosphatase (ALP) level \> 1.5 × ULN. * Have untreated or uncontrolled hypothyroidism or hyperthyroidism. * Have obesity induced by other endocrinologic disorders. * Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years. * Have any lifetime history of a suicide attempt. * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within the past 5 years prior to screening. * Have had a transplanted organ (corneal transplants \[keratoplasty\] allowed) or awaiting an organ transplant. * Have any hematological condition that may interfere with HbA1c measurement (for example, hemolytic anemias, sickle cell disease). * Are receiving or have received within 3 months prior to screening chronic (\> 2 weeks or 14 days) systemic glucocorticoid therapy or have evidence of a significant active autoimmune abnormality that has required treatment within the last 3 months. * Have current or recent treatment with medications and/or supplements that may cause significant weight gain. * Currently receiving or planning to initiate during the study any muscle toning or body contouring treatments such as high-intensity focused electromagnetic therapy, or neurotoxin injections targeting large muscle groups (for example, trapezius, gastrocnemius) for slimming or relaxation purposes. * Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) or alternative remedies intended to promote weight loss. * Have started implantable or injectable contraceptives (such as Depo-Provera®) within 6 months prior to screening. * Documented moderate to severe obstructive sleep apnea (unless controlled by medically prescribed intervention for at least 3 months prior to screening). * Prior treatment with growth factors including, but not limited to, GH, IGF-1, and GH secretagogues.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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