DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07291232

RecruitingPhase 1

A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Subcutaneous Doses of ABBV-295 in Adult Subjects With Obesity

Lead sponsor

AbbVie

Asset

ABBV-295

Subcutaneous · Amylin analog

Listed sites

2

Recruiting sites

2

Enrollment

48

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-45

Primary endpoints

•Adverse Events (AEs)•Vital Sign Measurements•Electrocardiogram (ECG)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07291232
Org study IDM26-089

Timeline

Milestones

Study start2025-11-19actual
Study first posted2025-12-18actual
Last update posted2026-05-19actual
Primary completion2026-10estimated (month precision)
Study completion2026-10estimated (month precision)

Assets

Investigational agents

ABBV-295

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•BMI ≥ 30.0 to ≤ 45.0 kg/m2 after rounding to the tenths decimal at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with or without weight related stable comorbidities (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
•A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.

Exclusion criteria

•Participant has a self-reported change in body weight ≥ 5% within 3 months prior to Screening.
•HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening.
•Participant has taken a medication for the purpose of treating obesity or has been enrolled in an obesity trial within 180 days prior to study treatment administration.

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

Safety / tolerability / PK
13
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Percent Change in Body Weight From Baseline

Time frame:Up to approximately 145 days

percent change from baseline, improvement

Safety / tolerability / PK

13 endpoints
Primary/protocol endpoint

Number of Participants with Adverse Events (AEs)

Time frame:Up to approximately 145 days

event count, event

Primary/protocol endpoint

Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements

Time frame:Up to approximately 145 days

change from baseline, event

Primary/protocol endpoint

Number of Participants with Change from Baseline in Electrocardiogram (ECG)

Time frame:Up to approximately 145 days

change from baseline, event

Primary/protocol endpoint

Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed

Time frame:Up to approximately 145 days

change from baseline, event

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of ABBV-295

Time frame:Up to approximately 145 days

concentration, descriptive

Primary/protocol endpoint

Time to Cmax (Tmax) of ABBV-295

Time frame:Up to approximately 145 days

time to event, event

Primary/protocol endpoint

Trough plasma concentration (Ctrough) of ABBV-295

Time frame:Up to approximately 145 days

concentration, descriptive

Primary/protocol endpoint

Terminal phase elimination half-life (t1/2) of ABBV-295

Time frame:Up to approximately 145 days

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration-time curve (AUC) of ABBV-295

Time frame:Up to approximately 145 days

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295

Time frame:Up to approximately 145 days

concentration, descriptive

Primary/protocol endpoint

Dose Normalized Cmax of ABBV-295

Time frame:Up to approximately 145 days

concentration, descriptive

Primary/protocol endpoint

Dose Normalized AUC of ABBV-295

Time frame:Up to approximately 145 days

concentration, descriptive

Primary/protocol endpoint

Incidence of Anti-Drug Antibodies (ADAs)

Time frame:Up to approximately 145 days

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Apparent terminal phase elimination rate constant (BETA) of ABBV-295

Time frame:Up to approximately 145 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.