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Obesity & OverweightPhase 2NCT07754045

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

A Phase 2 study testing LUM-201 and Semagludtide in people with Obesity & Overweight, run by Lumos Pharma.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 84 years
Conditions the study is for
Obesity & Overweight
What is being tested?
LUM-201 and Semagludtide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
No sites listed yet
Study dates
15 Feb 2027to 15 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Have a known clinically significant gastric emptying abnormality.
  • Have a history of chronic or acute pancreatitis, or severe gastroesophageal reflux disease and symptomatic cholelithiasis with intact gallbladder.
  • Have serum lipase and/or amylase above 1.5 × the upper limit of normal (ULN).
  • Have a history of hepatic disorders including cirrhosis or other hepatic disorder other than metabolic-associated fatty liver disease (MAFLD), or nonalcoholic fatty liver disease.
  • Have active hepatitis B or C virus at screening. Have known positive history of human immunodeficiency virus. Have an active Coronavirus Disease 2019 at screening.
  • Have an impaired liver function, defined as screening aspartate aminotransferase (AST) > 2.5 × ULN, or alanine aminotransferase > 2.5 × ULN, or total bilirubin level > 1.2 × ULN (except for cases of known Gilbert's Syndrome).
  • Alkaline phosphatase (ALP) level > 1.5 × ULN.
  • Have untreated or uncontrolled hypothyroidism or hyperthyroidism.
  • Have obesity induced by other endocrinologic disorders.
  • Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years.
  • Have any lifetime history of a suicide attempt.
  • Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within the past 5 years prior to screening.
  • Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an organ transplant.
  • Have any hematological condition that may interfere with HbA1c measurement (for example, hemolytic anemias, sickle cell disease).
  • Are receiving or have received within 3 months prior to screening chronic (> 2 weeks or 14 days) systemic glucocorticoid therapy or have evidence of a significant active autoimmune abnormality that has required treatment within the last 3 months.
  • Have current or recent treatment with medications and/or supplements that may cause significant weight gain.
  • Currently receiving or planning to initiate during the study any muscle toning or body contouring treatments such as high-intensity focused electromagnetic therapy, or neurotoxin injections targeting large muscle groups (for example, trapezius, gastrocnemius) for slimming or relaxation purposes.
  • Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) or alternative remedies intended to promote weight loss.
  • Have started implantable or injectable contraceptives (such as Depo-Provera®) within 6 months prior to screening.
  • Documented moderate to severe obstructive sleep apnea (unless controlled by medically prescribed intervention for at least 3 months prior to screening).
  • Prior treatment with growth factors including, but not limited to, GH, IGF-1, and GH secretagogues.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lumos Pharma contact

515-296-5555

clinical.trials@lumos-pharma.com

About this study

Official title: Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of Oral LUM-201 as an Adjunct to Oral Semaglutide for Improving Physical Function in Older Adults With Obesity

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.

Being tested
LUM-201, Placebo, Semagludtide
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LUM-201Drug

    Daily (AM) oral Tablet at 25 mg

  • PlaceboDrug

    Daily (AM) oral Tablet

  • SemagludtideDrug

    Daily (AM) oral Tablet

Study groups in NCT07754045
Study groupRoleWhat they receive
LUM-201 plus SemaglutideExperimentalNot described
Receives: Drug: LUM-201; Drug: Semagludtide
Semaglutide plus placeboPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Semagludtide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From Day 1 to week 26

Secondary outcomes (17)

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

    Measured: Day 1 to week 26.

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

    Measured: Day 1 to week 26.

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

    Measured: Day 1 to week 26.

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

    Measured: Day 1 to week 26.

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

    Measured: Day 1 to week 26.

  6. Change from baseline to Week 26 in waist:height ratio.

    Measured: Day 1 to week 26.

  7. 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.

    Measured: Day 1 to week 26

  8. Change from Baseline to Week 26 in Individual Short Physical Performance Battery (SPPB) Test.

    Measured: Day 1 to week 26

  9. Difference in proportions of participants achieving a clinically meaningful positive Short Physical Performance Battery (SPPB) change (1-point).

    Measured: Day 1 to week 26

  10. Change from Baseline to Week 26 in mean Short Physical Performance Battery (SPPB).

    Measured: Day 1 to week 26

  11. Change from Baseline to Week 26 in Stair Climb (Power/Time).

    Measured: Day 1 to week 26

  12. Change from Baseline to Week 26 in 6 Minute Walk Test (6MWT).

    Measured: Day 1 to week 26

  13. Change from Baseline to Week 26 in Grip Strength in kg using a hand dynamometer.

    Measured: Day 1 to week 26

  14. Change from Baseline to Week 26 in Knee extension.

    Measured: Day 1 to week 26

  15. Change from Baseline to Week 26 in Patient reported Outcome (PRO) questionnaire Short Form-36 (SF-36) score.

    Measured: Day 1 to week 26

  16. Change from Baseline to Week 26 in Patient reported Outcome (PRO) questionnaire Impact of Weight on Quality of Life-Lite (IWQoL-Lite) score.

    Measured: Day 1 to week 26

  17. Change from Baseline to Week 26 in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue measurements score.

    Measured: Day 1 to week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start15 Feb 2027 (estimated)
  3. Primary completion15 Feb 2028 (estimated)
  4. Study completion15 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
202 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07754045
Sponsor's protocol ID
LUM-201-20
Status last verified
Jul 2026
First submitted
9 Jul 2026
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LUM-201 and Semagludtide in people with Obesity & Overweight, run by Lumos Pharma.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lumos Pharma (515-296-5555, clinical.trials@lumos-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07754045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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