NCT07754045尚未招募2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Lumos Pharma
- 入组人数
- 202
- 主要终点
- Proportion of participants with Short Physical Performance Battery (SPPB) score ≤ 7 at Week 26.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •SPPB score at the screening visit ≥ 7 to ≤
- •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.
排除标准
- •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 m
- •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
- •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.
研究组 & 干预措施
LUM-201 plus Semaglutide
Experimental
干预措施: Semagludtide (Drug)
Semaglutide plus placebo
Placebo Comparator
干预措施: Placebo (Drug)
Semaglutide plus placebo
Placebo Comparator
干预措施: Semagludtide (Drug)
LUM-201 plus Semaglutide
Experimental
干预措施: LUM-201 (Drug)
结局指标
主要结局
Proportion of participants with Short Physical Performance Battery (SPPB) score ≤ 7 at Week 26.
时间窗: From Day 1 to week 26
次要结局
- 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.)
- Change from baseline to Week 26 in waist:height ratio.(Day 1 to week 26.)
- Assess safety and tolerability of LUM-201 in the presence of semaglutide.(Day 1 to week 26)
- Change from Baseline to Week 26 in Individual Short Physical Performance Battery (SPPB) Test.(Day 1 to week 26)
- Difference in proportions of participants achieving a clinically meaningful positive Short Physical Performance Battery (SPPB) change (1-point).(Day 1 to week 26)
- Change from Baseline to Week 26 in mean Short Physical Performance Battery (SPPB).(Day 1 to week 26)
- Change from Baseline to Week 26 in Stair Climb (Power/Time).(Day 1 to week 26)
- Change from Baseline to Week 26 in 6 Minute Walk Test (6MWT).(Day 1 to week 26)
- Change from Baseline to Week 26 in Grip Strength in kg using a hand dynamometer.(Day 1 to week 26)
- Change from Baseline to Week 26 in Knee extension.(Day 1 to week 26)
- Change from Baseline to Week 26 in Patient reported Outcome (PRO) questionnaire Short Form-36 (SF-36) score.(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.(Day 1 to week 26)
- Change from Baseline to Week 26 in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue measurements score.(Day 1 to week 26)
研究者
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