Healthy VolunteerPhase 1NCT07514260
A Study to Assess Adverse Events, Tolerability, and Pharmacokinetics of Subcutaneous Injections of ABBV-295 in Healthy Adult Japanese Participants With Overweight or Obesity.
A Phase 1 study testing ABBV-295 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-295
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese participant must be first-or second-generation Japanese of full Japanese parentage.
- First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent.
- Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.
- BMI is ≥ 23.0 to ≤ 35.0 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.
Who cannot join
- 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 (e.g. Glucagon-like peptide-1, (GLP-1) agonists, Glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) agonists, bupropion-naltrexone, orlistat, metformin, phentermine-topiramate, amphetamine based stimulants, methylphenidate) or has been enrolled in an obesity trial within 180 days prior to study treatment administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
CenExel Act- Anaheim Clinical Trials /ID# 280879
Anaheim, California, 92801
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-295 in Healthy Japanese Subjects With Overweight or Obesity
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.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-295, Placebo for ABBV-295
- Keywords
- Healthy Volunteer, ABBV-295
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-295Drug
Subcutaneous Injections
Placebo for ABBV-295Drug
Subcutaneous Injections
| Study group | Role | What they receive |
|---|---|---|
| ABBV-295 Part 1 | Experimental | Participants will receive subcutaneous doses of ABBV-295 for 12 weeks. Receives: Drug: ABBV-295 |
| Placebo for ABBV-295 Part 1 | Experimental | Participants will receive subcutaneous doses of placebo for 12 weeks. Receives: Drug: Placebo for ABBV-295 |
| ABBV-295 Part 2 | Experimental | Participants will receive subcutaneous doses of ABBV-295 for 12 weeks. Receives: Drug: ABBV-295 |
| Placebo for ABBV-295 Part 2 | Experimental | Participants will receive subcutaneous doses of placebo for 12 weeks. Receives: Drug: Placebo for ABBV-295 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 138 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start31 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514260
- Sponsor's protocol ID
- M26-009
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-295 in Healthy Japanese Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07514260
- Acronym / sponsor ID
- M26-009
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-295
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABBV-295 Part 1 | Experimental | Drug: ABBV-295Participants will receive subcutaneous doses of ABBV-295 for 12 weeks. |
| Placebo for ABBV-295 Part 1 | Experimental | Drug: Placebo for ABBV-295Participants will receive subcutaneous doses of placebo for 12 weeks. |
| ABBV-295 Part 2 | Experimental | Drug: ABBV-295Participants will receive subcutaneous doses of ABBV-295 for 12 weeks. |
| Placebo for ABBV-295 Part 2 | Experimental | Drug: Placebo for ABBV-295Participants will receive subcutaneous doses of placebo for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Japanese participant must be first-or second-generation Japanese of full Japanese parentage.
- BMI is ≥ 23.0 to ≤ 35.0 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.
Key exclusion criteria (3 listed)
- 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 (e.g. Glucagon-like peptide-1, (GLP-1) agonists, Glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) agonists, bupropion-naltrexone, orlistat, metformin, phentermine-topiramate, amphetamine based stimulants, methylphenidate) or has been enrolled in an obesity trial within 180 days prior to study treatment administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-295Subcutaneous Injections | Drug | ABBV-295 Part 1, ABBV-295 Part 2 |
| Placebo for ABBV-295Subcutaneous Injections | Drug | Placebo for ABBV-295 Part 1, Placebo for ABBV-295 Part 2 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 138 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-295 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 138 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.