Recruiting NCT07291232
A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABBV-295, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug ABBV-295
Subcutaneous Injections - Drug Placebo
Subcutaneous Injections
Primary outcome measures
- Number of Participants with Adverse Events (AEs) [Time frame: Up to approximately 194 days]
- Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [Time frame: Up to approximately 194 days]
- Number of Participants with Change from Baseline in Electrocardiogram (ECG) [Time frame: Up to approximately 194 days]
- Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [Time frame: Up to approximately 194 days]
- Maximum Observed Plasma Concentration (Cmax) of ABBV-295 [Time frame: Up to approximately 194 days]
- Time to Cmax (Tmax) of ABBV-295 [Time frame: Up to approximately 194 days]
- Trough plasma concentration (Ctrough) of ABBV-295 [Time frame: Up to approximately 194 days]
- Apparent terminal phase elimination rate constant (BETA) of ABBV-295 [Time frame: Up to approximately 194 days]
- Terminal phase elimination half-life (t1/2) of ABBV-295 [Time frame: Up to approximately 194 days]
- Area under the plasma concentration-time curve (AUC) of ABBV-295 [Time frame: Up to approximately 194 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- CenExel Act- Anaheim Clinical Trials /ID# 283200 — Anaheim
- Acpru /Id# 278624 — Grayslake
Identifiers
NCT: NCT07291232 · M26-089