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
New drug KAI-7535 tested for weight loss in adults with obesity
Plain English Summary
Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity is a Phase 2 clinical trial sponsored by Kailera studying Obesity, Overweight. This study tests an oral medication called KAI-7535 to see if it helps adults lose weight. It is for adults who are overweight or have obesity and have at least one weight-related health problem, like high blood pressure or high cholesterol. Participants will take either KAI-7535 or a placebo (a sugar pill) by mouth daily for about 44 weeks. Alternatives include lifestyle changes (diet and exercise) and other approved weight-loss medications. The trial aims to enroll 320 participants.
Official 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. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with a BMI of 30 or higher, or 27 or higher with a weight-related condition (like high blood pressure, high cholesterol, sleep apnea, or heart disease). Adults with type 2 diabetes and a BMI of 27 or higher, who are on stable diabetes treatment. You cannot join if you have diabetes and are taking medication for blood sugar control (unless you have type 2 diabetes). You cannot join if you have had recent pancreatitis, certain eye conditions related to diabetes, or certain psychiatric disorders. This trial is studying Obesity, Overweight, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see how much body weight is lost after 44 weeks of taking KAI-7535 compared to a placebo, which will show how effective the drug is for weight loss. The specific primary outcome measures are: Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus (Baseline, Week 44). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses the significant need for new, effective weight management options for individuals struggling with obesity and its associated health issues. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Obesity, Overweight, where improved treatment options are needed.
Investor Insight
This trial signals potential for a new oral treatment in the large and growing obesity market, with a focus on patients with comorbidities, potentially offering a competitive advantage if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of KAI-7535 and how it compares to other treatments. Participation involves taking a daily pill and attending regular clinic visits for check-ups and monitoring. You will need to track your weight and report any side effects or changes in your health. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 320 participants
Interventions
- DRUG: KAI-7535 — Oral tablets
- DRUG: Placebo — Oral tablets
Primary Outcomes
- Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus (Baseline, Week 44)
Secondary Outcomes
- Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus (Baseline, Week 44)
- Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus (Baseline, Week 44)
- Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus (Week 44)
- Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus (Baseline, Week 44)
- Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus (Baseline, Week 44)
Frequently Asked Questions
What is clinical trial NCT07497880?
NCT07497880 is a Phase 2 INTERVENTIONAL study titled "Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity." It is currently not yet recruiting and is sponsored by Kailera. The trial targets enrollment of 320 participants.
What conditions does NCT07497880 study?
This trial investigates treatments for Obesity, Overweight. The primary condition under study is Obesity.
What treatments are being tested in NCT07497880?
The interventions being studied include: KAI-7535 (DRUG), Placebo (DRUG). Oral tablets
What does Phase 2 mean for NCT07497880?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07497880?
This trial is currently "Not Yet Recruiting." It started on 2026-04-01. The estimated completion date is 2027-07-07.
Who is sponsoring NCT07497880?
NCT07497880 is sponsored by Kailera. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07497880?
The trial aims to enroll 320 participants. The trial has not yet started recruiting.
How is NCT07497880 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07497880?
The primary outcome measures are: Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus (Baseline, Week 44). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07497880?
The official record for NCT07497880 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07497880. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07497880 testing in simple terms?
This study tests an oral medication called KAI-7535 to see if it helps adults lose weight. It is for adults who are overweight or have obesity and have at least one weight-related health problem, like high blood pressure or high cholesterol.
Why is this trial significant?
This trial addresses the significant need for new, effective weight management options for individuals struggling with obesity and its associated health issues.
What are the potential risks of participating in NCT07497880?
Common side effects may include gastrointestinal issues like nausea, vomiting, or diarrhea. There is a risk of developing pancreatitis, though it is rare. Potential for serious side effects related to heart or mental health conditions, though these are closely monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07497880?
Ask your doctor about the potential benefits and risks of KAI-7535 and how it compares to other treatments. Participation involves taking a daily pill and attending regular clinic visits for check-ups and monitoring. You will need to track your weight and report any side effects or changes in your health. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07497880 signal from an investment perspective?
This trial signals potential for a new oral treatment in the large and growing obesity market, with a focus on patients with comorbidities, potentially offering a competitive advantage if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will take either KAI-7535 or a placebo (a sugar pill) by mouth daily for about 44 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.