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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
202
Daily (AM) oral Tablet at 25 mg
Daily (AM) oral Tablet
Daily (AM) oral Tablet
Proportion of participants with Short Physical Performance Battery (SPPB) score ≤ 7 at Week 26.
Time frame: From Day 1 to week 26
Change from baseline to Week 26 in total body fat mass (kg) measured by dual-energy X-ray absorptiometry (DEXA).
Time frame: Day 1 to week 26.
Change from baseline to Week 26 in total lean mass (kg) measured by dual-energy X-ray absorptiometry (DEXA).
Time frame: Day 1 to week 26.
Change from baseline to Week 26 in fat-free mass (kg) measured by dual-energy X-ray absorptiometry (DEXA).
Time frame: Day 1 to week 26.
Change from baseline to Week 26 in body weight (kg).
Time frame: Day 1 to week 26.
Change from baseline to Week 26 in waist:hip ratio.
Time frame: Day 1 to week 26.
Change from baseline to Week 26 in waist:height ratio.
Time frame: Day 1 to week 26.
Assess safety and tolerability of LUM-201 in the presence of semaglutide.
Incidence of treatment emergent adverse events, adverse events (AEs), and serious adverse events (SAEs). Clinically significant changes from Baseline to Week 26 in safety evaluations.
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in Individual Short Physical Performance Battery (SPPB) Test.
Time frame: Day 1 to week 26
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Difference in proportions of participants achieving a clinically meaningful positive Short Physical Performance Battery (SPPB) change (1-point).
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in mean Short Physical Performance Battery (SPPB).
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in Stair Climb (Power/Time).
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in 6 Minute Walk Test (6MWT).
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in Grip Strength in kg using a hand dynamometer.
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in Knee extension.
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in Patient reported Outcome (PRO) questionnaire Short Form-36 (SF-36) score.
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in Patient reported Outcome (PRO) questionnaire Impact of Weight on Quality of Life-Lite (IWQoL-Lite) score.
Time frame: Day 1 to week 26
Change from Baseline to Week 26 in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue measurements score.
Time frame: Day 1 to week 26