Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Obesity & Overweight

In brief

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.

Key facts

Study ID: NCT07754045
Run by: Lumos Pharma
People needed: 202
Starts: 2027-02-15
Expected to finish: 2028-02-15
Last updated by the study team: 2026-08-10

Who can join

Age: 60 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Full record on ClinicalTrials.gov

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