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

NCT07754045 | Not Yet Recruiting Phase 2

• 1 other identifier: LUM-201-20
• Study Type: interventional
• Target: 202
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Short Physical Performance Battery (SPPB) score ≤ 7 at Week 26.

  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).

  Day 1 to week 26.

• Change from baseline to Week 26 in total lean mass (kg) measured by dual-energy X-ray absorptiometry (DEXA).

  Day 1 to week 26.

• Change from baseline to Week 26 in fat-free mass (kg) measured by dual-energy X-ray absorptiometry (DEXA).

  Day 1 to week 26.

• Change from baseline to Week 26 in body weight (kg).

  Day 1 to week 26.

• Change from baseline to Week 26 in waist:hip ratio.

  Day 1 to week 26.

Study Arms (2)

LUM-201 plus Semaglutide

EXPERIMENTAL

Drug: LUM-201; Drug: Semagludtide

Semaglutide plus placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Semagludtide

Interventions

LUM-201 DRUG

Daily (AM) oral Tablet at 25 mg

LUM-201 plus Semaglutide

Placebo DRUG

Daily (AM) oral Tablet

Semaglutide plus placebo

Semagludtide DRUG

Daily (AM) oral Tablet

LUM-201 plus Semaglutide; Semaglutide plus placebo

Eligibility Criteria

• Age: 60 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 a history of ≥ 1 self-reported unsuccessful dietary effort to lose weight.
• Female participants must be postmenopausal, confirmed by an follicle stimulating hormone (FSH) level ≥ 25 IU/L.
• Male participants must be able to comply with contraception requirements.
• Must agree to refrain from any reconstructive and/or cosmetic surgery and/or non-invasive cosmetic procedure that may affect body weight during the study such as mammoplasty, lipoplasty, non-invasive adipose and/or cellulite treatment devices.
• Must refrain from scheduling any elective surgery and/or other invasive or non-invasive procedures during the study unless medically warranted.

You may not qualify if:

• 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.
• Have a BMI \> 45 kg/m2 or weight \> 159 kg (350 lbs.).
• Have a self-reported change in body weight \> 5 kg (11 lbs.) within 3 months prior to screening.
• Have received prior exposure to a GLP-1 receptor agonist (including dual GLP-1/ GIP receptor agonists\]) within 180 days before screening, any other anti-obesity medication, glucose-lowering agent (non-GLP-1), or glucose lowering supplements such as berberine, etc. within 90 days before screening.
• Have any other condition not listed in this section (for example, hypersensitivity or intolerance) that is a contraindication to GLP-1 receptor agonist or dual GLP-1/GIP receptor agonist.
• Have serum calcitonin concentration \> 35 pg/mL at screening.
• Have a history of prior or planned surgical treatment for obesity.
• Have uncontrolled hypertension with systolic blood pressure (SBP) ≥ 150 mm Hg and/or diastolic blood pressure (DBP) ≥ 95 mm Hg.
• Mean QTcF (Fridericia \[QTcF=QT/RR1/3\]) interval \> 450 ms (male) or \> 470 ms (female) on triplicate ECGs.
• Have fasting triglyceride \> 500 mg/dL.
• Have any of the following within last 6 months prior to screening: NYHA Functional Classification I-IV heart failure, myocardial infarction, angina, coronary artery bypass graft, percutaneous coronary intervention, transient ischemic attack, stroke, or decompensated congestive heart failure.
• Have an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2.

Sponsors & Collaborators

• Lumos Pharma: lead

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lumos Pharma

CONTACT

515-296-5555; clinical.trials@lumos-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): February 15, 2027
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): February 15, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-07