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

Sponsor
Lumos Pharma
Study ID
NCT07754045
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
60 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • LUM-201 — DRUG
    Daily (AM) oral Tablet at 25 mg
  • Placebo — DRUG
    Daily (AM) oral Tablet
  • Semagludtide — DRUG
    Daily (AM) oral Tablet

Study Details

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 Dates

First listed
Aug 10, 2026
Start date
Feb 15, 2027
Status verified
Jul 2026
Primary completion
Feb 15, 2028
Completion
Feb 15, 2028

Study Design

Enrollment
202 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LUM-201 plus Semaglutide
  • Placebo Comparator: Semaglutide plus placebo

Primary Outcome Measure

Proportion of participants with Short Physical Performance Battery (SPPB) score ≤ 7 at Week 26. [ Time Frame: From Day 1 to week 26 ]

Central Contacts

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