ObesityPhase 1NCT07291232
A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity
A Phase 1 study testing ABBV-295 in people with Obesity, run by AbbVie at 2 sites in United States.
Trial summary
This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- 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
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2025to Apr 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
- BMI ≥ 30.0 to ≤ 45.0 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) with or without weight related stable comorbidities (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
- A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.
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 or has been enrolled in an obesity trial within 180 days prior to study treatment administration.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CenExel Act- Anaheim Clinical Trials /ID# 283200
Anaheim, California, 92801
Acpru /Id# 278624
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Subcutaneous Doses of ABBV-295 in Adult Subjects With Obesity
This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo.
- Conditions
- Obesity
- Being tested
- ABBV-295, Placebo
- Keywords
- Obesity, ABBV-295
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-295Drug
Subcutaneous Injections
PlaceboDrug
Subcutaneous Injections
| Study group | Role | What they receive |
|---|---|---|
| ABBV-295 or Placebo-Group 1 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 or Placebo-Group 2 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 or Placebo-Group 3 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 or Placebo-Group 3 Extension | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 or Placebo-Group 4 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 or Placebo-Group 4 Extension | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 or Placebo-Group 5 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 or Placebo-Group 6 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. Receives: Drug: ABBV-295; Drug: Placebo |
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 194 days
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed.
Measured: Up to approximately 194 days
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
12-lead resting ECG will be recorded.
Measured: Up to approximately 194 days
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.
Measured: Up to approximately 194 days
Maximum Observed Plasma Concentration (Cmax) of ABBV-295
Cmax of ABBV-295
Measured: Up to approximately 194 days
Time to Cmax (Tmax) of ABBV-295
Tmax of ABBV-295
Measured: Up to approximately 194 days
Trough plasma concentration (Ctrough) of ABBV-295
Ctrough of ABBV-295
Measured: Up to approximately 194 days
Apparent terminal phase elimination rate constant (BETA) of ABBV-295
BETA of ABBV-295
Measured: Up to approximately 194 days
Terminal phase elimination half-life (t1/2) of ABBV-295
t1/2 of ABBV-295
Measured: Up to approximately 194 days
Area under the plasma concentration-time curve (AUC) of ABBV-295
AUC of ABBV-295
Measured: Up to approximately 194 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295
AUCtau of ABBV-295
Measured: Up to approximately 194 days
Dose Normalized Cmax of ABBV-295
Dose normalized Cmax of ABBV-295 will be assessed.
Measured: Up to approximately 194 days
Dose Normalized AUC of ABBV-295
Dose normalized AUC of ABBV-295 will be assessed.
Measured: Up to approximately 194 days
Incidence of Anti-Drug Antibodies (ADAs)
Incidence of ADAs will be assessed.
Measured: Up to approximately 194 days
Percent Change in Body Weight From Baseline
Percent change in body weight (kg) will be assessed.
Measured: Up to approximately 194 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start19 Nov 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT07291232
- Sponsor's protocol ID
- M26-089
- Status last verified
- Nov 2026
- First submitted
- 19 Nov 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Subcutaneous Doses of ABBV-295 in Adult Subjects With Obesity
- ClinicalTrials.gov ID
- NCT07291232
- Acronym / sponsor ID
- M26-089
- Conditions
- Obesity
- Keywords
- Obesity, ABBV-295
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Dec 2025 (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.
This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ABBV-295 or Placebo-Group 1 | Experimental | Drug: ABBV-295, Drug: PlaceboParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 2 | Experimental | Drug: ABBV-295, Drug: PlaceboParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 3 | Experimental | Drug: ABBV-295, Drug: PlaceboParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 3 Extension | Experimental | Drug: ABBV-295, Drug: PlaceboParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. |
| ABBV-295 or Placebo-Group 4 | Experimental | Drug: ABBV-295, Drug: PlaceboParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 4 Extension | Experimental | Drug: ABBV-295, Drug: PlaceboParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. |
| ABBV-295 or Placebo-Group 5 | Experimental | Drug: ABBV-295, Drug: PlaceboParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
| ABBV-295 or Placebo-Group 6 | Experimental | Drug: ABBV-295, Drug: PlaceboParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥ 30.0 to ≤ 45.0 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) with or without weight related stable comorbidities (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
- A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.
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 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 or Placebo-Group 1, ABBV-295 or Placebo-Group 2, ABBV-295 or Placebo-Group 3, ABBV-295 or Placebo-Group 3 Extension, ABBV-295 or Placebo-Group 4, ABBV-295 or Placebo-Group 4 Extension, ABBV-295 or Placebo-Group 5, ABBV-295 or Placebo-Group 6 |
| PlaceboSubcutaneous Injections | Drug | ABBV-295 or Placebo-Group 1, ABBV-295 or Placebo-Group 2, ABBV-295 or Placebo-Group 3, ABBV-295 or Placebo-Group 3 Extension, ABBV-295 or Placebo-Group 4, ABBV-295 or Placebo-Group 4 Extension, ABBV-295 or Placebo-Group 5, ABBV-295 or Placebo-Group 6 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 194 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.
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Time frame: Up to approximately 194 days
Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed.
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Time frame: Up to approximately 194 days
12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Time frame: Up to approximately 194 days
Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.
Maximum Observed Plasma Concentration (Cmax) of ABBV-295
Time frame: Up to approximately 194 days
Cmax of ABBV-295
Time to Cmax (Tmax) of ABBV-295
Time frame: Up to approximately 194 days
Tmax of ABBV-295
Trough plasma concentration (Ctrough) of ABBV-295
Time frame: Up to approximately 194 days
Ctrough of ABBV-295
Apparent terminal phase elimination rate constant (BETA) of ABBV-295
Time frame: Up to approximately 194 days
BETA of ABBV-295
Terminal phase elimination half-life (t1/2) of ABBV-295
Time frame: Up to approximately 194 days
t1/2 of ABBV-295
Area under the plasma concentration-time curve (AUC) of ABBV-295
Time frame: Up to approximately 194 days
AUC of ABBV-295
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295
Time frame: Up to approximately 194 days
AUCtau of ABBV-295
Dose Normalized Cmax of ABBV-295
Time frame: Up to approximately 194 days
Dose normalized Cmax of ABBV-295 will be assessed.
Dose Normalized AUC of ABBV-295
Time frame: Up to approximately 194 days
Dose normalized AUC of ABBV-295 will be assessed.
Incidence of Anti-Drug Antibodies (ADAs)
Time frame: Up to approximately 194 days
Incidence of ADAs will be assessed.
Percent Change in Body Weight From Baseline
Time frame: Up to approximately 194 days
Percent change in body weight (kg) will be assessed.
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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
2 sites 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 Obesity, run by AbbVie at 2 sites 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 2 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 194 days). The study lists 15 primary outcomes in all. 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 5 Nov 2026.