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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: ABBV-295

Study type: Interventional

Funder types: Industry

Identifiers

NCT07291232

M26-089

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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96 participants in 6 patient groups

ABBV-295 or Placebo-Group 1

Experimental group

Description:

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

Treatment:

Drug: ABBV-295

Drug: Placebo

ABBV-295 or Placebo-Group 2

Experimental group

Description:

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

Treatment:

Drug: ABBV-295

Drug: Placebo

ABBV-295 or Placebo-Group 3

Experimental group

Description:

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

Treatment:

Drug: ABBV-295

Drug: Placebo

ABBV-295 or Placebo-Group 4

Experimental group

Description:

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

Treatment:

Drug: ABBV-295

Drug: Placebo

ABBV-295 or Placebo-Group 5-Optional

Experimental group

Description:

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

Treatment:

Drug: ABBV-295

Drug: Placebo

ABBV-295 or Placebo-Group 6

Experimental group

Description:

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

Treatment:

Drug: ABBV-295

Drug: Placebo