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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-84
SponsorLumos Pharma

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LUM-201
  • Placebo
  • Semagludtide

Treatment groups

202 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators