Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07497880 · ClinicalTrials.gov registry record · Phase 2
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, sponsored by Kailera.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
NCT07497880: Recruiting Phase 2 study, sponsored by Kailera.
NCT07497880 is a Phase 2 study that is actively recruiting participants, run by Kailera. The registered enrollment target is 320 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07497880, a Phase 2 study, is actively recruiting participants, sponsored by Kailera.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG KAI-7535
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2026-04-06 |
| Est. Completion | 2027-07-07 |
| Phase | Phase 2 |
What NCT07497880 shows while recruiting
NCT07497880 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07497880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07497880 about?
NCT07497880 is a clinical study titled "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. Efficacy in participants with ...
What is the current status of trial NCT07497880?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2026-04-06. Estimated completion is 2027-07-07.
What interventions are being tested in trial NCT07497880?
The interventions under investigation include: Placebo (DRUG), KAI-7535 (DRUG).
Who is sponsoring clinical trial NCT07497880?
This trial is sponsored by Kailera, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07497880's enrollment target sits among peer trials
320 152nd of 2000 higher than 1,848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02763683 · 320 participants
Investigations of Dementia in Parkinson Disease
- NCT03331198 · 320 participants · Phase 1
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- NCT03458832 · 320 participants
Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD
- NCT03551951 · 320 participants
Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI