Placebo for ABBV-295 / ABBV-295 / Healthy Volunteer · Phase 1 Trial

A Study to Assess Adverse Events, Tolerability, and Pharmacokinetics of Subcutaneous Injections of ABBV-295 in Healthy Adult Japanese Participants With Overweight or Obesity.

ClinicalTrials.gov · August 14, 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 1 clinical trial registration for ABBV-295, a subcutaneous agent, in healthy Japanese adults with overweight or obesity. The study is designed to characterize safety, tolerability, and pharmacokinetics; no results are posted in this registry record and the trial remains active.

What was studied

Phase 1, Interventional, Randomized, Parallel, Triple masking, Basic Science purpose. Healthy Volunteer; age from 18 Years; to 65 Years. Intervention: ABBV-295 Part 1; Placebo for ABBV-295 Part 1; ABBV-295 Part 2; Placebo for ABBV-295 Part 2. Compared with: Placebo for ABBV-295. n = 24. 1 site: United States.

Key findings

Safety

Study is Phase 1, limited to safety and PK characterization; no efficacy data presented or expected. Primary outcome is adverse events, not a clinical or hard endpoint.

Who this may help

No clinical impact can be assessed; this is a safety and tolerability study in healthy volunteers, not designed to establish efficacy or clinical benefit. Results are not yet available.

Plain-language summary

Phase 1 safety and tolerability study in healthy volunteers with no results posted; designed to characterize adverse events and pharmacokinetics of a novel agent, not efficacy or clinical benefit.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Number of Participants with Adverse Events (AEs) (assessed at Up to approximately 138 days)

DesignPhase 1, Interventional, Randomized, Parallel, Triple masking, Basic Science purpose

PopulationHealthy Volunteer; age from 18 Years; to 65 Years

Sample size24

InterventionABBV-295 Part 1; Placebo for ABBV-295 Part 1; ABBV-295 Part 2; Placebo for ABBV-295 Part 2

ComparatorPlacebo for ABBV-295

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment24

Phase1

Primary outcome measureNumber of Participants with Adverse Events (AEs), up to approximately 138 days

Study statusACTIVE_NOT_RECRUITING

Clinical bottom line

No clinical impact can be assessed; this is a safety and tolerability study in healthy volunteers, not designed to establish efficacy or clinical benefit. Results are not yet available.

Caveats

This is a registry record; no results are reported or posted.
Study is Phase 1, limited to safety and PK characterization; no efficacy data presented or expected.
Small sample (n=24) and healthy volunteer population limit generalizability to patients with obesity-related disease.
Primary outcome is adverse events, not a clinical or hard endpoint.

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 1 interventional design with placebo comparator; appropriate for initial safety assessment.

Directness

limited

Healthy volunteers with overweight/obesity; does not assess efficacy or clinical outcomes.

Consistency

insufficient

Registry record; no comparative data or replication reported.

Risk of bias

insufficient

Registry record; no methodological details on blinding, randomisation, or conduct provided.

Sample adequacy

limited

Planned enrollment 24 participants; appropriate for Phase 1 dose escalation and safety.

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 (NCT07514260). This is a study registration, not published results. Lead sponsor: AbbVie. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 24 participants (ACTUAL). Conditions: Healthy Volunteer. Interventions: DRUG: ABBV-295; DRUG: Placebo for ABBV-295. Primary outcome measures: Number of Participants with Adverse Events (AEs) , Up to approximately 138 days. Brief summary: The purpose of this study is to assess the adverse events, tolerability, and Pharmacokinetics (PK) of subcutaneous injections of ABBV-295 in healthy adult Japanese participants with overweight or obesity.

Follow from this

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

Placebo for ABBV-295ABBV-295AbbvieNCT07514260Healthy Volunteer