Healthy VolunteerPhase 1NCT07414784
A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives
A Phase 1 study testing ABBV-295 and Levonorgestrel/Ethinyl Estradiol in people with Healthy Volunteer, run by AbbVie at 2 sites in United States.
Trial summary
This Study of ABBV-295 subcutaneous injections will assess pharmacokinetics and adverse events in healthy adult women participants with overweight or obesity taking oral contraceptives. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-295 and Levonorgestrel/Ethinyl Estradiol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2026to 4 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 25.0 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)
- 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 90 days prior to study treatment administration.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CenExel Act- Anaheim Clinical Trials /ID# 281863
Anaheim, California, 92801
Acpru /Id# 280538
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1 Drug-Drug Interaction Study of ABBV-295, Levonorgestrel, and Ethinyl Estradiol in Healthy Adult Female Subjects With Overweight or Obesity
This Study of ABBV-295 subcutaneous injections will assess pharmacokinetics and adverse events in healthy adult women participants with overweight or obesity taking oral contraceptives.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-295, Levonorgestrel/Ethinyl Estradiol
- 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
Levonorgestrel/Ethinyl EstradiolDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| ABBV-295 with Levonorgestrel and Ethinyl Estradiol | Experimental | Participants will receive subcutaneous doses of ABBV-295 with levonorgestrel and ethinyl estradiol for 68 days. Receives: Drug: ABBV-295; Drug: Levonorgestrel/Ethinyl Estradiol |
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 128 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start11 Feb 2026
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07414784
- Sponsor's protocol ID
- M26-006
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2026
- Last updated
- 31 Aug 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Drug-Drug Interaction Study of ABBV-295, Levonorgestrel, and Ethinyl Estradiol in Healthy Adult Female Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07414784
- Acronym / sponsor ID
- M26-006
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-295
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 17 Feb 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.
This Study of ABBV-295 subcutaneous injections will assess pharmacokinetics and adverse events in healthy adult women participants with overweight or obesity taking oral contraceptives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-295 with Levonorgestrel and Ethinyl Estradiol | Experimental | Drug: ABBV-295, Drug: Levonorgestrel/Ethinyl EstradiolParticipants will receive subcutaneous doses of ABBV-295 with levonorgestrel and ethinyl estradiol for 68 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥ 25.0 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)
- 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 90 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 with Levonorgestrel and Ethinyl Estradiol |
| Levonorgestrel/Ethinyl EstradiolOral Tablet | Drug | ABBV-295 with Levonorgestrel and Ethinyl Estradiol |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 128 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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
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 and Levonorgestrel/Ethinyl Estradiol in people with Healthy Volunteer, 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: finished, as of the sponsor's last update on 31 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 128 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 31 Aug 2026.