Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
Recruiting
Phase 2Interventional Study
ObesityOverweight
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
360 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for adults with obesity or overweight who have weight-related health issues. Participants will receive injections of either the study drug ABBV-295 or a placebo for 52 weeks, and their progress will be monitored through regular visits and assessments.
Are You a Good Fit for This Trial?
You may be able to join if
I have a BMI of 30 or higher
I have a BMI between 27 and 30 and have a weight-related health issue
You may not be able to join if
I have lost or gained more than 5% of my body weight in the last 3 months
I have a hemoglobin A1c level of 6.5% or higher
I have high fasting glucose or random glucose levels
I have a history of type 1 or type 2 diabetes
I have taken any medication for obesity or weight management in the last 180 days
I have had serious cardiovascular issues in the last 180 days
I have a disease or condition that poses a risk or may affect my participation
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 devel…
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.
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Eligibility Criteria
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 fo…
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.
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