NCT05295875已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled and Parallel Group 48-Week Study to Evaluate the Efficacy and Safety of ALT-801 in the Treatment of Obesity (MOMENTUM Trial)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 4
- 主要终点
- Relative change from baseline in body weight percentage
研究概览
简要总结
This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in patients with obesity/overweight.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed prior to entry into the study
- •Male or female age 18 to 75 years, inclusive
- •Body mass index (BMI) ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 combined with at least one obesity-related comorbidity
- •At least one unsuccessful weight loss attempt per investigator judgement
- •Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study
- •Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control
排除标准
- •Weight gain or loss > 5% in the 3 months prior to randomization or >10% in the 6 months prior to screening
- •Diabetes and related conditions:
- •History or clinical evidence of diabetes mellitus of any type, including Type 1, Type 2, or mature onset diabetes of the young (MODY)
- •HbA1c > 6.5%, fasting glucose ≥ 126 mg/dL (6.9 mmol/L), and/or random glucose of ≥ 200 mg/dL (11.0mmol/L) at screening
- •Obesity and related conditions:
- •Obesity induced by known genetic causes or endocrine disorders (eg, Cushing Syndrome, inadequately treated hypothyroidism, defined as thyroid-stimulating hormone [TSH] > 6 mIU/L)
- •History of bariatric surgery or other surgical treatment for obesity (eg, gastric banding, gastric bypass), or planned surgery or surgical treatment during the study. Liposuction and/or abdominoplasty performed >1 year before screening is allowed. Endoscopically placed intragastric balloons will be allowed if removed > 1 year before screening.
- •Gastrointestinal conditions:
- •History of acute or chronic pancreatitis within 1 year (365 days) before screening
- •History of or acute significant gastrointestinal (GI) disorder (eg, peptic ulcers, severe gastroesophageal reflux disease [GERD],
- •History of GI surgery, including cholecystectomy and antrectomy. Surgery for appendicitis and small bowel resection >20cm is acceptable.
- •History of inflammatory bowel disease, celiac disease or any medical condition or surgery that could affect gastric emptying, stool frequency or stool consistency. (Irritable bowel syndrome is permitted provided that bowel frequency and consistency are normal off treatment.)
- •Mental health conditions:
- •Untreated depressive disorder, defined as a Patient Health Questionaire-9 (PHQ-9) score of ≥ 15 at screening
- •Suicide ideation, defined as type 4 or 5 on the Columbia-Suicide Severity Rating Scale(C-SSRS) at screening, lifelong history of a suicide attempt, or suicidal behavior within 30 days before screening
- •Other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)
研究组 & 干预措施
ALT-801 Dose Level 1
Experimental
干预措施: ALT-801 (Drug)
ALT-801 Dose Level 2
Experimental
干预措施: ALT-801 (Drug)
ALT-801 Dose Level 3
Experimental
干预措施: ALT-801 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Relative change from baseline in body weight percentage
时间窗: Baseline to Week 48
次要结局
- Changes from baseline in Hemoglobin A1c(Baseline to Week 48)
- Change from baseline in proportion of patients using antihypertensive medications(Baseline to Week 48)
- Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure(Baseline to Week 48)
- Percent proportion of subjects with weight loss of greater than or equal to 5%, 10%, and 15%(Baseline to Week 48)
- The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)(Baseline to Week 48)
- Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR)(Baseline to Week 48)
- Changes from baseline in Fasting Glucose(Baseline to Week 48)
- Change from baseline in lipids(Baseline to Week 48)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial CancerTransitional Cell Carcinoma of BladderUrethra CancerUreter CancerMalignant Tumor of Renal PelvisNCT01326871Altor BioScience68
终止
2 期
Study to Assess the Effects of PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALSAmyotrophic Lateral SclerosisNCT05349721PTC Therapeutics336
撤回
2 期
Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative ColitisUlcerative ColitisNCT05121402TLL Pharmaceutical, LLC
已完成
1 期
The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult MalesHealthy VolunteersNCT04347005Arthrosi Therapeutics64
终止
1 期
QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple MyelomaRelapsed or Refractory Multiple MyelomaNCT01670994Altor BioScience6