Obesity / ABBV-295 / Overweight · Phase 2 Trial

Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 clinical trial registration for ABBV-295, an investigational long-acting amylin analog for weight management in adults with obesity or overweight and weight-related comorbidities. The study is currently recruiting and has not yet reported results; it is designed to assess dose-dependent effects on body weight reduction and safety through 52 weeks of follow-up.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity, Overweight; age from 18 Years; to 75 Years. Intervention: ABBV-295 Arm 1; ABBV-295 Arm 2; ABBV-295 Arm 3; ABBV-295 Arm 4; ABBV-295 Arm 5; ABBV-295 Arm 6. Compared with: Placebo — Placebo Comparator. n = 360. 40 sites: United States, Puerto Rico.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 trial registration with no results posted; it describes planned enrollment and outcome measures only, representing early-stage efficacy and safety evaluation of an investigational agent.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Percent Change From Baseline in Body Weight (assessed at Baseline (Week 0) to Week 32); Number of Participants with Adverse Events (AEs) (assessed at Up to approximately week 52)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationObesity, Overweight; age from 18 Years; to 75 Years

Sample size360

InterventionABBV-295 Arm 1; ABBV-295 Arm 2; ABBV-295 Arm 3; ABBV-295 Arm 4; ABBV-295 Arm 5; ABBV-295 Arm 6

ComparatorPlacebo — Placebo Comparator

Setting40 sites: United States, Puerto Rico

Reported figures

Quoted from the source exactly as published.

Planned enrollment360

Primary outcome: body weight changePercent Change From Baseline in Body Weight, Baseline (Week 0) to Week 32

Primary outcome: adverse eventsNumber of Participants with Adverse Events (AEs), Up to approximately week 52

Study sitesapproximately 70

GeographyUnited States and Puerto Rico

Caveats

No results are reported in this registry record; the trial is still recruiting
Phase 2 design limits generalizability to efficacy in larger, more diverse populations
Allocation concealment method and specific weight-related comorbidities required for enrollment are not detailed
Study burden acknowledged; comparison to standard-of-care outcomes not yet available

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2, randomized, placebo-controlled, double-blind design with multiple dose groups.

Directness

moderate

Primary endpoints are body weight change and adverse events; clinically relevant outcomes.

Consistency

insufficient

No results reported; consistency cannot be assessed against prior data.

Risk of bias

moderate

Double-blind, placebo-controlled design reduces bias; allocation concealment not described.

Sample adequacy

limited

Phase 2 trial; 360 estimated participants across multiple dose groups limits power per arm.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07752979). This is a study registration, not published results. Lead sponsor: AbbVie. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 360 participants (ESTIMATED). Conditions: Obesity, Overweight. Interventions: DRUG: ABBV-295; DRUG: Placebo. Primary outcome measures: Percent Change From Baseline in Body Weight , Baseline (Week 0) to Week 32; Number of Participants with Adverse Events (AEs) , Up to approximately week 52. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityABBV-295OverweightAbbvieNCT07752979