ObesityPhase 1NCT07294898
A Study to Investigate the Effect of a Low-fat Meal and Evening Dosing on KAI-7535 in Participants Living With Obesity or Overweight
A Phase 1 study testing KAI-7535 in people with Obesity and Overweight, run by Kailera at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants living with obesity or overweight. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- KAI-7535
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 26 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥25.0 and ≤40.0 kg/m^2.
- Medically healthy, as determined by prestudy medical history, and without clinically significant (CS) abnormalities.
Who cannot join
- Known hypersensitivity to study treatment or any study treatment ingredients.
- History or presence of CS cardiovascular, pulmonary, hepatic, renal, hematological, GI, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of a Low-Fat Meal and Evening Dosing on the Pharmacokinetics of KAI-7535 in Healthy Participants Living With Obesity or Overweight
The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants living with obesity or overweight.
- Conditions
- Obesity, Overweight
- Being tested
- KAI-7535
- Keywords
- Obesity, Overweight, Glucagon-like peptide-1, GLP-1, KAI-7535
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAI-7535Drug
Oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| KAI-7535: Morning Dosing, Fed | Experimental | Participants will receive KAI-7535 in the morning following a meal on dosing days. Receives: Drug: KAI-7535 |
| KAI-7535: Morning Dosing, Fasted | Experimental | Participants will receive KAI-7535 in the morning following an overnight fast on dosing days. Receives: Drug: KAI-7535 |
| KAI-7535: Evening Dosing | Experimental | Participants will receive KAI-7535 in the evening on dosing days. Receives: Drug: KAI-7535 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Maximum Observed Concentration (Tmax) of KAI-7535
Measured: Pre-dose and up to 60 hours post-dose
Maximum Observed Concentration (Cmax) of KAI-7535
Measured: Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535
Measured: Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535
Measured: Pre-dose and up to 60 hours post-dose
Secondary outcomes (1)
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Measured: Day 1 up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Dec 2025
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kailera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294898
- Sponsor's protocol ID
- K7535-1709
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 29 Jan 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of a Low-Fat Meal and Evening Dosing on the Pharmacokinetics of KAI-7535 in Healthy Participants Living With Obesity or Overweight
- ClinicalTrials.gov ID
- NCT07294898
- Acronym / sponsor ID
- K7535-1709
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Overweight, Glucagon-like peptide-1, GLP-1, KAI-7535
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- KaileraIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 19 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.
The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants living with obesity or overweight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KAI-7535: Morning Dosing, Fed | Experimental | Drug: KAI-7535Participants will receive KAI-7535 in the morning following a meal on dosing days. |
| KAI-7535: Morning Dosing, Fasted | Experimental | Drug: KAI-7535Participants will receive KAI-7535 in the morning following an overnight fast on dosing days. |
| KAI-7535: Evening Dosing | Experimental | Drug: KAI-7535Participants will receive KAI-7535 in the evening on dosing days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) ≥25.0 and ≤40.0 kg/m^2.
- Medically healthy, as determined by prestudy medical history, and without clinically significant (CS) abnormalities.
Key exclusion criteria (3 listed)
- Known hypersensitivity to study treatment or any study treatment ingredients.
- History or presence of CS cardiovascular, pulmonary, hepatic, renal, hematological, GI, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
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 |
|---|---|---|
| KAI-7535Oral tablets. | Drug | KAI-7535: Evening Dosing, KAI-7535: Morning Dosing, Fasted, KAI-7535: Morning Dosing, Fed |
Primary outcome
Time to Maximum Observed Concentration (Tmax) of KAI-7535
Time frame: Pre-dose and up to 60 hours post-dose
Maximum Observed Concentration (Cmax) of KAI-7535
Time frame: Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535
Time frame: Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535
Time frame: Pre-dose and up to 60 hours post-dose
1 secondary outcome
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 up to Day 12
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 29 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
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 KAI-7535 in people with Obesity and Overweight, run by Kailera 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 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 29 Jan 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?
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?
Time to Maximum Observed Concentration (Tmax) of KAI-7535 (time frame: Pre-dose and up to 60 hours post-dose). The study lists 4 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 29 Jan 2026.