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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

Lead sponsor

AbbVie

Asset

ABBV-295

Subcutaneous · Amylin analog

Listed sites

64

Recruiting sites

64

Estimated enrollment

360

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoints

•Body Weight•Adverse Events (AEs)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07752979
Org study IDM25-998

Timeline

Milestones

Study start2026-08-04actual
Study first posted2026-08-07actual
Last update posted2026-10-27actual
Primary completion2028-03estimated (month precision)
Study completion2028-03estimated (month precision)

Assets

Investigational agents

ABBV-295

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
14
Safety / tolerability / PK
1

Weight & body composition

14 endpoints
Primary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline (Week 0) to Week 32

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline (Week 0) through Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight From Baseline

Time frame:Baseline (Week 0) through Week 32

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight From Baseline

Time frame:Baseline (Week 0) through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index From Baseline

Time frame:Baseline (Week 0) through Week 32

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index From Baseline

Time frame:Baseline (Week 0) through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference From Baseline

Time frame:Baseline (Week 0) through Week 32

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference From Baseline

Time frame:Baseline (Week 0) through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame:Week 32

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame:Week 32

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:Week 32

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:Week 52

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Participants with Adverse Events (AEs)

Time frame:Up to approximately week 52

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.