A Phase 2 Dose-Finding Study to Assess the Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 45
- 主要终点
- Percent Change From Baseline in Body Weight
研究概览
简要总结
Obesity is a condition where a person has excessive body fat, defined by a body mass index (BMI) of 30 kg/m2 or higher. The goal of this study is to evaluate the effect of various doses of ABBV-295 compared to placebo on reducing body weight at Week 32 in participants with obesity or overweight with weight-related comorbidities.
ABBV-295 is an investigational long-acting amylin analog being developed for chronic weight management. Participants are placed into multiple treatment groups with different dosing paradigms of ABBV-295 or placebo. Participants will not know which treatment they are receiving, and there is a chance of being assigned to placebo. Adults with obesity or overweight (as defined by BMI) with weight-related comorbidities will be enrolled. Approximately 360 participants will be enrolled in the study at approximately 70 sites in the United States and Puerto Rico.
Participants will receive subcutaneous (SC) injections of ABBV-295 solution for injection or matching placebo administered via pre-filled syringes for 52 weeks during the Double-Blind Period.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •BMI ≥ 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) OR
- •BMI ≥ 27.0 to < 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with at least one of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, metabolic dysfunction-associated steatotic liver disease (MASLD).
排除标准
- •Self-reported change in body weight ≥ 5% within 3 months prior to Screening
- •Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
- •Fasting glucose ≥126 mg/dL (7.0 mmol/L) or random glucose test ≥ 200 mg/dL (11.1 mmol/L)
- •History of type 1 or type 2 diabetes mellitus
- •Treatment with any medication or product used for obesity or weight management within 180 days prior to Screening Unstable or severe cardiovascular disease (e.g., myocardial infarction, stroke, hospitalization for: unstable angina pectoris, transient ischemic attack, or heart failure) within 180 days prior to Screening.
- •The participant has a concurrent disease, condition, or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
研究组 & 干预措施
ABBV-295 Arm 1
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: Placebo (Drug)
ABBV-295 Arm 1
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: ABBV-295 (Drug)
ABBV-295 Arm 3
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: ABBV-295 (Drug)
ABBV-295 Arm 2
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: ABBV-295 (Drug)
ABBV-295 Arm 2
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: Placebo (Drug)
ABBV-295 Arm 5
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: ABBV-295 (Drug)
ABBV-295 Arm 5
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: Placebo (Drug)
ABBV-295 Arm 3
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: Placebo (Drug)
ABBV-295 Arm 4
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: ABBV-295 (Drug)
ABBV-295 Arm 4
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: Placebo (Drug)
ABBV-295 Arm 6
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: ABBV-295 (Drug)
ABBV-295 Arm 6
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
干预措施: Placebo (Drug)
Placebo
Participants will follow the same dosing schedule as active treatment arms during the Double-Blind Period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight
时间窗: Baseline (Week 0) to Week 32
The primary efficacy endpoint is the percent change from baseline in body weight. This measure assesses the effect of various doses of ABBV-295 compared to placebo on reducing body weight in subjects with obesity or overweight with weight-related comorbidities.
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately week 52
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
次要结局
- Percent Change From Baseline in Body Weight(Baseline (Week 0) through Week 52)
- Change in Body Weight From Baseline(Baseline (Week 0) through Week 32)
- Change in Body Weight From Baseline(Baseline (Week 0) through Week 52)
- Change in Body Mass Index From Baseline(Baseline (Week 0) through Week 32)
- Change in Body Mass Index From Baseline(Baseline (Week 0) through Week 52)
- Change in Waist Circumference From Baseline(Baseline (Week 0) through Week 32)
- Change in Waist Circumference From Baseline(Baseline (Week 0) through Week 52)
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction(Week 32)
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction(Week 52)
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Week 32)
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Week 52)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Week 32)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Week 52)