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NCT Number: NCT07752979

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-295

Drug

Subcutaneous

Placebo

Drug

Subcutaneous

Primary outcomes

  1. Percent Change From Baseline in Body Weight

    Time frame: 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.

  2. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

Secondary outcomes

  1. Percent Change From Baseline in Body Weight

    Time frame: Baseline (Week 0) through Week 52

    Percent change from baseline in body weight

  2. Change in Body Weight From Baseline

    Time frame: Baseline (Week 0) through Week 32

    Change in body weight (kg) from baseline

  3. Change in Body Weight From Baseline

    Time frame: Baseline (Week 0) through Week 52

    Change in body weight (kg) from baseline

  4. Change in Body Mass Index From Baseline

    Time frame: Baseline (Week 0) through Week 32

    Change in BMI (kg/m2) from baseline

  5. Change in Body Mass Index From Baseline

    Time frame: Baseline (Week 0) through Week 52

    Change in BMI (kg/m2) from baseline

  6. Change in Waist Circumference From Baseline

    Time frame: Baseline (Week 0) through Week 32

    Change in waist circumference (cm) from baseline

  7. Change in Waist Circumference From Baseline

    Time frame: Baseline (Week 0) through Week 52

    Change in waist circumference (cm) from baseline

  8. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Time frame: Week 32

    Percentage of participants who achieve ≥5% body weight reduction

  9. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Time frame: Week 52

    Percentage of participants who achieve ≥5% body weight reduction

  10. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Time frame: Week 32

    Percentage of participants who achieve ≥10% body weight reduction

  11. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Time frame: Week 52

    Percentage of participants who achieve ≥10% body weight reduction

  12. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Time frame: Week 32

    Percentage of participants who achieve ≥15% body weight reduction

  13. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Time frame: Week 52

    Percentage of participants who achieve ≥15% body weight reduction

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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