Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07291232

Recruiting nowPhase 1Interventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry 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.

Treatments and study arms

ABBV-295

Drug

Subcutaneous Injections

Placebo

Drug

Subcutaneous Injections

Primary outcomes

Number of Participants with Adverse Events (AEs)Up to approximately 194 days

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Number of Participants with Abnormal Change From Baseline in Vital Sign MeasurementsUp to approximately 194 days

Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed.

Number of Participants with Change from Baseline in Electrocardiogram (ECG)Up to approximately 194 days

12-lead resting ECG will be recorded.

Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be AssessedUp to approximately 194 days

Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.

Maximum Observed Plasma Concentration (Cmax) of ABBV-295Up to approximately 194 days

Cmax of ABBV-295

Time to Cmax (Tmax) of ABBV-295Up to approximately 194 days

Tmax of ABBV-295

Trough plasma concentration (Ctrough) of ABBV-295Up to approximately 194 days

Ctrough of ABBV-295

Apparent terminal phase elimination rate constant (BETA) of ABBV-295Up to approximately 194 days

BETA of ABBV-295

Study locations

2 locations were listed when this page was built. The first 40 are shown.

CenExel Act- Anaheim Clinical Trials /ID# 283200🇺🇸 Anaheim, California, United States

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Acpru /Id# 278624🇺🇸 Grayslake, Illinois, United States

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