Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAbbVie
About this trial
Obesity is a condition where a person has excessive body fat, defined by a body mass index (BMI) of 30 kg/m2 or higher. The goal of this study is to evaluate the effect of various doses of ABBV-295 compared to placebo on reducing body weight at Week 32 in participants with obesity or overweight with weight-related comorbidities.
ABBV-295 is an investigational long-acting amylin analog being developed for chronic weight management. Participants are placed into multiple treatment groups with different dosing paradigms of ABBV-295 or placebo. Participants will not know which treatment they are receiving, and there is a chance of being assigned to placebo. Adults with obesity or overweight (as defined by BMI) with weight-related comorbidities will be enrolled. Approximately 360 participants will be enrolled in the study at approximately 70 sites in the United States and Puerto Rico.
Participants will receive subcutaneous (SC) injections of ABBV-295 solution for injection or matching placebo administered via pre-filled syringes for 52 weeks during the Double-Blind Period.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI ≥ 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) OR
BMI ≥ 27.0 to < 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with at least one of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, metabolic dysfunction-associated steatotic liver disease (MASLD).
Disqualifiers
Self-reported change in body weight ≥ 5% within 3 months prior to Screening
Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
Fasting glucose ≥126 mg/dL (7.0 mmol/L) or random glucose test ≥ 200 mg/dL (11.1 mmol/L)
History of type 1 or type 2 diabetes mellitus
Trial design
Design model
Parallel
Treatments tested in this trial
ABBV-295
DrugSubcutaneous
Placebo
DrugSubcutaneous
Treatment groups
360 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: ABBV-295 Arm 1Experimental treatment 2 interventions
Group B: ABBV-295 Arm 2Experimental treatment 2 interventions
Group C: ABBV-295 Arm 3Experimental treatment 2 interventions
Group D: ABBV-295 Arm 4Experimental treatment 2 interventions
Group E: ABBV-295 Arm 5Experimental treatment 2 interventions
Group F: ABBV-295 Arm 6Experimental treatment 2 interventions
Group G: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change From Baseline in Body Weight
The primary efficacy endpoint is the percent change from baseline in body weight. This measure assesses the effect of various doses of ABBV-295 compared to placebo on reducing body weight in subjects with obesity or overweight with weight-related comorbidities.
Time frame
Baseline (Week 0) to Week 322
Number of Participants with Adverse Events (AEs)
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.
Time frame
Up to approximately week 52Secondary outcomes
1
Percent Change From Baseline in Body Weight
Percent change from baseline in body weight
Time frame
Baseline (Week 0) through Week 522
Change in Body Weight From Baseline
Change in body weight (kg) from baseline
Time frame
Baseline (Week 0) through Week 323
Change in Body Weight From Baseline
Change in body weight (kg) from baseline
Time frame
Baseline (Week 0) through Week 524
Change in Body Mass Index From Baseline
Change in BMI (kg/m2) from baseline
Time frame
Baseline (Week 0) through Week 32 Source ClinicalTrials.gov