A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity
ConditionObesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbbVie
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- ABBV-295
- Placebo
Treatment groups
80 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov