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

NCT ID: NCT07291232

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-19

Study Completion Date

2026-10-31

Brief Summary

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This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo.

Detailed Description

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Conditions

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Obesity

Keywords

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Obesity ABBV-295

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ABBV-295 or Placebo-Group 1

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

Group Type EXPERIMENTAL

ABBV-295

Intervention Type DRUG

Subcutaneous Injections

Placebo

Intervention Type DRUG

Subcutaneous Injections

ABBV-295 or Placebo-Group 2

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

Group Type EXPERIMENTAL

ABBV-295

Intervention Type DRUG

Subcutaneous Injections

Placebo

Intervention Type DRUG

Subcutaneous Injections

ABBV-295 or Placebo-Group 3

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

Group Type EXPERIMENTAL

ABBV-295

Intervention Type DRUG

Subcutaneous Injections

Placebo

Intervention Type DRUG

Subcutaneous Injections

ABBV-295 or Placebo-Group 4

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

Group Type EXPERIMENTAL

ABBV-295

Intervention Type DRUG

Subcutaneous Injections

Placebo

Intervention Type DRUG

Subcutaneous Injections

ABBV-295 or Placebo-Group 5-Optional

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

Group Type EXPERIMENTAL

ABBV-295

Intervention Type DRUG

Subcutaneous Injections

Placebo

Intervention Type DRUG

Subcutaneous Injections

ABBV-295 or Placebo-Group 6

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

Group Type EXPERIMENTAL

ABBV-295

Intervention Type DRUG

Subcutaneous Injections

Placebo

Intervention Type DRUG

Subcutaneous Injections

Interventions

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ABBV-295

Subcutaneous Injections

Intervention Type DRUG

Placebo

Subcutaneous Injections

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Acpru /Id# 278624

Grayslake, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

Phone: 844-663-3742

Email: [email protected]

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M26-089

Related Info

Other Identifiers

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M26-089

Identifier Type: -

Identifier Source: org_study_id