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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks
  • Procedures mentioned: Injections, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether different doses of ABBV-295, an experimental medicine, safely help adults lose weight by week 32. It is for adults with obesity, or those who are overweight and have a weight-related health problem. Participants receive shots under the skin of ABBV-295 or a placebo (a shot with no study medicine) for 52 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a BMI of 30 or higher at screening. BMI is a measure of weight compared with height.
  • Or, have a BMI of 27 to less than 30 at screening and at least one of these: high blood pressure, unhealthy blood fat levels, sleep apnea (breathing stops and starts during sleep), heart or blood vessel disease, or MASLD (fat buildup in the liver linked to problems with how the body uses food for energy).

Who can't join

  • Report a weight change of 5% or more in the 3 months before screening.
  • Have an HbA1c of 6.5% or higher at screening. This blood test measures average blood sugar.
  • Have blood sugar of 126 mg/dL or higher after fasting (not eating), or 200 mg/dL or higher on a test taken at any time.
  • Have a history of type 1 or type 2 diabetes.
  • Used any medicine or product for obesity or weight control in the 180 days before screening.
  • Had unstable or severe heart or blood vessel disease in the 180 days before screening, such as a heart attack, stroke, or hospital stay for unstable chest pain, a mini-stroke, or heart failure.
  • Have another illness, condition, or situation that the study doctor thinks could cause serious risk, affect study results, or make it much harder to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (59)

AL

AZ

CA

FL

GA

ID

IL

KY

MO

MS

MT

NC

ND

NV

NY

OH

TN

TX

VA

WA