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.
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 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.
Parallel
LUM-201
DrugDaily (AM) oral Tablet at 25 mg
Placebo
DrugDaily (AM) oral Tablet
Semagludtide
DrugDaily (AM) oral Tablet
Proportion of participants with Short Physical Performance Battery (SPPB) score ≤ 7 at Week 26.
Change from baseline to Week 26 in total body fat mass (kg) measured by dual-energy X-ray absorptiometry (DEXA).
Change from baseline to Week 26 in total lean mass (kg) measured by dual-energy X-ray absorptiometry (DEXA).
Change from baseline to Week 26 in fat-free mass (kg) measured by dual-energy X-ray absorptiometry (DEXA).
Change from baseline to Week 26 in body weight (kg).
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This trial is not recruiting at the moment. You can still explore other options:
