Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities

Phase 2RecruitingNCT07752979

AbbVie360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

360

Conditions

Obesity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Percent Change From Baseline in Body Weight

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.

Time frame: Baseline (Week 0) to Week 32

Number of Participants with Adverse Events (AEs)

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.

Time frame: Up to approximately week 52

Secondary Outcomes

Percent Change From Baseline in Body Weight

Percent change from baseline in body weight

Time frame: Baseline (Week 0) through Week 52

Change in Body Weight From Baseline

Change in body weight (kg) from baseline

Time frame: Baseline (Week 0) through Week 32

Change in Body Weight From Baseline

Change in body weight (kg) from baseline

Time frame: Baseline (Week 0) through Week 52

Change in Body Mass Index From Baseline

Change in BMI (kg/m2) from baseline

Time frame: Baseline (Week 0) through Week 32

Change in Body Mass Index From Baseline

Change in BMI (kg/m2) from baseline

Time frame: Baseline (Week 0) through Week 52

Change in Waist Circumference From Baseline

Change in waist circumference (cm) from baseline

Time frame: Baseline (Week 0) through Week 32

Change in Waist Circumference From Baseline

Change in waist circumference (cm) from baseline

Time frame: Baseline (Week 0) through Week 52

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Percentage of participants who achieve ≥5% body weight reduction

Time frame: Week 32

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Percentage of participants who achieve ≥5% body weight reduction

Time frame: Week 52

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Percentage of participants who achieve ≥10% body weight reduction

Time frame: Week 32

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Percentage of participants who achieve ≥10% body weight reduction

Time frame: Week 52

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Percentage of participants who achieve ≥15% body weight reduction

Time frame: Week 32

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Percentage of participants who achieve ≥15% body weight reduction

Time frame: Week 52

Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities

Overview

Conditions

Interventions

Eligibility

Locations (46)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts