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

NCT07752979 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: M25-998
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Overweight

Keywords

Obesity; Overweight; ABBV-295

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately week 52

Secondary Outcomes (13)

• 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

Study Arms (7)

ABBV-295 Arm 1

EXPERIMENTAL

Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

Drug: ABBV-295; Drug: Placebo

ABBV-295 Arm 2

EXPERIMENTAL

Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

Drug: ABBV-295; Drug: Placebo

ABBV-295 Arm 3

EXPERIMENTAL

Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

Drug: ABBV-295; Drug: Placebo

ABBV-295 Arm 4

EXPERIMENTAL

Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

Drug: ABBV-295; Drug: Placebo

ABBV-295 Arm 5

EXPERIMENTAL

Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

Drug: ABBV-295; Drug: Placebo

ABBV-295 Arm 6

EXPERIMENTAL

Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

Drug: ABBV-295; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will follow the same dosing schedule as active treatment arms during the Double-Blind Period.

Drug: Placebo

Interventions

ABBV-295 DRUG

Subcutaneous

ABBV-295 Arm 1; ABBV-295 Arm 2; ABBV-295 Arm 3; ABBV-295 Arm 4; ABBV-295 Arm 5; ABBV-295 Arm 6

Placebo DRUG

Subcutaneous

ABBV-295 Arm 1; ABBV-295 Arm 2; ABBV-295 Arm 3; ABBV-295 Arm 4; ABBV-295 Arm 5; ABBV-295 Arm 6; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/