ObesityPhase 2NCT07497880
Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
A Phase 2 study testing KAI-7535 in people with Obesity and Overweight, run by Kailera at 36 sites in 2 countries.
Trial summary
The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 6 Apr 2026to 7 Jul 2027
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m^2) or BMI ≥27 kg/m^2 and a previous diagnosis of at least 1 of the following:
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea
- Cardiovascular disease
- For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m^2 only:
- Diagnosis of type 2 diabetes mellitus
- On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening
Who cannot join
- For participants without diabetes:
- Laboratory evidence of diabetes
- Taking a concomitant medication for the indication of glycemic control
- For participants living with type 2 diabetes mellitus only:
- History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
- History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
Show all 17Show fewer
- History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
- Started medications that may cause significant weight change within 3 months prior to screening, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers
- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to screening
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma
- Uncontrolled hypertension or unstable cardiovascular disease
- History of chronic or acute pancreatitis
- Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility
- History of suicide attempt
- History of significant active or unstable major depressive disorder or other severe psychiatric disorder
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3 months prior to screening
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States31 sites
Kailera Clinical Site
Austin, Texas, 78705
Kailera Clinical Site
Austin, Texas, 78757
Kailera Clinical Site
Brownsville, Texas, 78520
Kailera Clinical Site
Chandler, Arizona, 85225
Kailera Clinical Site
Chicago, Illinois, 60640
Kailera Clinical Site
Decatur, Georgia, 30030
Kailera Clinical Site
Farmers Branch, Texas, 75234
Kailera Clinical Site
Fort Worth, Texas, 76135
Kailera Clinical Site
Garden City, Michigan, 48135
Kailera Clinical Site
Hamden, Connecticut, 06517
Kailera Clinical Site
Irvine, California, 92614
Kailera Clinical Site
Jacksonville, Florida, 32256
Kailera Clinical Site
Jefferson City, Missouri, 65109
Kailera Clinical Site
Jupiter, Florida, 33458
Kailera Clinical Site
Kansas City, Missouri, 64151
Kailera Clinical Site
Kenner, Louisiana, 70065
Kailera Clinical Site
Knoxville, Tennessee, 37909
Kailera Clinical Site
Lincoln, California, 95648
Kailera Clinical Site
Mesquite, Texas, 75149
Kailera Clinical Site
Northridge, California, 91325
Kailera Clinical Site
Palm Springs, Florida, 33461
Kailera Clinical Site
Pembroke Pines, Florida, 33024
Kailera Clinical Site
Phoenix, Arizona, 85044
Kailera Clinical Site
San Antonio, Texas, 78222
Kailera Clinical Site
San Antonio, Texas, 78229
Kailera Clinical Site
San Antonio, Texas, 78240
Kailera Clinical Site
Sandy City, Utah, 84093
Kailera Clinical Site
Skokie, Illinois, 60077
Kailera Clinical Site
South Bend, Indiana, 46617
Kailera Clinical Site
Spartanburg, South Carolina, 29303
Kailera Clinical Site
Sugar Land, Texas, 77479
Australia5 sites
Kailera Clinical Site
Altona N., Victoria, 3025
Kailera Clinical Site
Dee Why, New South Wales, 2100
Kailera Clinical Site
Miranda, New South Wales, 2228
Kailera Clinical Site
Norwood, South Australia, 5067
Kailera Clinical Site
Wollongong, New South Wales, 2500
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Safety and tolerability and other weight-related outcomes will also be evaluated.
- Conditions
- Obesity, Overweight
- Being tested
- KAI-7535, Placebo
- Keywords
- Obesity, Overweight, Glucagon-like peptide-1, GLP-1, KAI-7535, Diabetes, Oral
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAI-7535Drug
Oral tablets
PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| KAI-7535: Dose Schedule 1 | Experimental | Participants will receive KAI-7535 once daily. Receives: Drug: KAI-7535 |
| KAI-7535: Dose Schedule 2 | Experimental | Participants will receive KAI-7535 once daily. Receives: Drug: KAI-7535 |
| KAI-7535: Dose Schedule 3 | Experimental | Participants will receive KAI-7535 once daily. Receives: Drug: KAI-7535 |
| KAI-7535: Dose Schedule 4 | Experimental | Participants will receive KAI-7535 once daily. Receives: Drug: KAI-7535 |
| Placebo | Placebo comparator | Participants will receive placebo matched to KAI-7535 once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Measured: Baseline, Week 44
Secondary outcomes (4)
Change from Baseline in Body Weight at Week 44
Measured: Baseline, Week 44
Change from Baseline in Body Mass Index (BMI) at Week 44
Measured: Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight
Measured: Week 44
Change from Baseline in Waist Circumference at Week 44
Measured: Baseline, Week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start6 Apr 2026
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Jul 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kailera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497880
- Sponsor's protocol ID
- K7535-2101
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
- ClinicalTrials.gov ID
- NCT07497880
- Acronym / sponsor ID
- K7535-2101
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Overweight, Glucagon-like peptide-1, GLP-1, KAI-7535, Diabetes, Oral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 306 participants (actual)
- Lead sponsor
- KaileraIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 27 Mar 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 primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Safety and tolerability and other weight-related outcomes will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| KAI-7535: Dose Schedule 1 | Experimental | Drug: KAI-7535Participants will receive KAI-7535 once daily. |
| KAI-7535: Dose Schedule 2 | Experimental | Drug: KAI-7535Participants will receive KAI-7535 once daily. |
| KAI-7535: Dose Schedule 3 | Experimental | Drug: KAI-7535Participants will receive KAI-7535 once daily. |
| KAI-7535: Dose Schedule 4 | Experimental | Drug: KAI-7535Participants will receive KAI-7535 once daily. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to KAI-7535 once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m^2) or BMI ≥27 kg/m^2 and a previous diagnosis of at least 1 of the following:
- For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m^2 only:
Key exclusion criteria (17 listed)
- For participants without diabetes:
- For participants living with type 2 diabetes mellitus only:
- Started medications that may cause significant weight change within 3 months prior to screening, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers
- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to screening
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma
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: Dose Schedule 1, KAI-7535: Dose Schedule 2, KAI-7535: Dose Schedule 3, KAI-7535: Dose Schedule 4 |
| PlaceboOral tablets | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Time frame: Baseline, Week 44
4 secondary outcomes
Change from Baseline in Body Weight at Week 44
Time frame: Baseline, Week 44
Change from Baseline in Body Mass Index (BMI) at Week 44
Time frame: Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight
Time frame: Week 44
Change from Baseline in Waist Circumference at Week 44
Time frame: Baseline, Week 44
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 9 Sep 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.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAI-7535 in people with Obesity and Overweight, run by Kailera at 36 sites in 2 countries.
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 8 inclusion and 17 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Australia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus (time frame: Baseline, Week 44). 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 9 Sep 2026.