Trial · Interventional
Not yet recruitingPhase 2Registry dataEvaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults
Overview
- Status
- Not yet recruiting
- Phase
- Phase 2
- Enrollment
- 202 participants (estimated)
- Sponsor
- Lumos Pharma · Industry
- Design
- Randomized · Triple masking
- Countries
- Not stated
- Start
- 15 Feb 2027 (estimated)
- Primary completion
- 15 Feb 2028 (estimated)
- Completion
- 15 Feb 2028 (estimated)
- First posted
- 10 Aug 2026
- Last update posted
- 10 Aug 2026
- Conditions
- Obesity & Overweight
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults
NCT07754045est. 15 Feb 2027 to est. 15 Feb 2028
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LUM-201Drug
- PlaceboDrug
- SemagludtideDrug
Arms2
Experimental
LUM-201 plus Semaglutide
Placebo comparator
Semaglutide plus placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Proportion of participants with Short Physical Performance Battery (SPPB) score ≤ 7 at Week 26.
Time frame · From Day 1 to week 26
Secondary outcomes(17)
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.
Time frame · Day 1 to week 26
Registry description
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.
Change from Baseline to Week 26 in Individual Short Physical Performance Battery (SPPB) Test.
Time frame · Day 1 to week 26
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 60 Years up to 84 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.