A Phase 2 interventional study of ABBV-295 and Placebo in Obesity and Overweight, sponsored by AbbVie. Recruiting at 64 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
This study's planned enrollment of 360 is above the median of 67 across 9,010 interventional studies indexed under Obesity.
Browse Obesity studies →AbbVie is the lead sponsor of 976 studies on the registry; 135 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
Drug: ABBV-295 · Drug: Placebo
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
Drug: ABBV-295 · Drug: Placebo
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
Drug: ABBV-295 · Drug: Placebo
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
Drug: ABBV-295 · Drug: Placebo
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
Drug: ABBV-295 · Drug: Placebo
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
Drug: ABBV-295 · Drug: Placebo
Participants will follow the same dosing schedule as active treatment arms during the Double-Blind Period.
Drug: Placebo
Subcutaneous
Subcutaneous
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 32
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 52
Percent Change From Baseline in Body Weight
Percent change from baseline in body weight
Time frame: Baseline (Week 0) through Week 52
Change in Body Weight From Baseline
Change in body weight (kg) from baseline
Time frame: Baseline (Week 0) through Week 32
Change in Body Weight From Baseline
Change in body weight (kg) from baseline
Time frame: Baseline (Week 0) through Week 52
Change in Body Mass Index From Baseline
Change in BMI (kg/m2) from baseline
Time frame: Baseline (Week 0) through Week 32
Change in Body Mass Index From Baseline
Change in BMI (kg/m2) from baseline
Time frame: Baseline (Week 0) through Week 52
Change in Waist Circumference From Baseline
Change in waist circumference (cm) from baseline
Time frame: Baseline (Week 0) through Week 32
Change in Waist Circumference From Baseline
Change in waist circumference (cm) from baseline
Time frame: Baseline (Week 0) through Week 52
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of participants who achieve ≥5% body weight reduction
Time frame: Week 32
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of participants who achieve ≥5% body weight reduction
Time frame: Week 52
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of participants who achieve ≥10% body weight reduction
Time frame: Week 32
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of participants who achieve ≥10% body weight reduction
Time frame: Week 52
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of participants who achieve ≥15% body weight reduction
Time frame: Week 32
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of participants who achieve ≥15% body weight reduction
Time frame: Week 52
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Mar 2028, 19 months after the start.
Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 19 months is above that.
Counting every sponsor, half of 307 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: ABBV-295