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Clinical Trial ● Currently Recruiting Phase III NCT07284875

Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes — Recruiting • Phase III • Diabetes /…

📅 18 Jun 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT07284875
Sponsor
Kailera
Start
2025-12-18
ClinicaliQ Trial Snapshot
  • Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes — Recruiting • Phase III • Diabetes / Metabolic • NCT07284875.
  • Treatment being tested: KAI-9531, a novel subcutaneous injection administered weekly, is being evaluated for its efficacy in reducing body weight compared to placebo in patients with obesity or overweight status.
  • Patient eligibility overview: The trial includes adults living with obesity or overweight who have weight-related comorbidities (such as hypertension or dyslipidaemia) but specifically excludes those with diabetes, allowing assessment of the drug's effects in a distinct patient population.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Eligibility Snapshot
  • : * BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of the following: 1. hypertension, 2. dyslipidemia, 3. obstructive sleep apnea, or 4. cardiovascular (CV) disease. * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Guideline
Semaglutide for Managing Overweight and Obesity (NICE TA875)
Diabetes / Metabolic · 27 Mar 2026
Initiate semaglutide only in specialist obesity services or via shared care with clear primary-secondary care protocols for adults with BMI ≥30 kg/m²…
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Guideline
Tirzepatide for Managing Overweight and Obesity (NICE TA1026)
Diabetes / Metabolic · 27 Mar 2026
Prescribe tirzepatide to adults with BMI ≥35 kg/m² or BMI 30–34.9 kg/m² with weight-related comorbidities, initiating treatment in specialist weight management services…
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Guideline
Obesity: Identification, Assessment and Management (NICE CG189)
Diabetes / Metabolic · 27 Mar 2026
Use BMI thresholds to identify obesity (≥30 kg/m² in adults; ≥27.5 kg/m² in Asian populations) and offer structured first-line weight loss interventions…
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Guideline
Metabolic dysfunction-associated steatotic liver disease (MASLD): assessment and management
Diabetes / Metabolic · 06 Jul 2016
Assess all patients with MASLD using FIB-4 index or transient elastography to stratify fibrosis risk—those with advanced fibrosis require specialist hepatology referral…
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Guideline
Non-Alcoholic Fatty Liver Disease: Assessment and Management (NICE NG49)
Diabetes / Metabolic · 27 Mar 2026
Use FIB-4 or NAFLD Fibrosis Score in primary care to stratify fibrosis risk in adults with metabolic risk factors (type 2 diabetes,…
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Clinical Brief
New drug to stop ‘Ozempic butt’ muscle loss side effect of obesity jabs
Diabetes / Metabolic · BBC Health · 08 Jun 2026
Weight loss from GLP-1 receptor agonists results in approximately 33% muscle loss alongside fat loss, necessitating clinical attention to body composition changes…
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