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Clinical Trial Active — Not Recruiting Phase II NCT06965413

A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity

A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One…

📅 13 May 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase II
NCT ID
NCT06965413
Start
2025-05-05
Completion
2026-08-24
ClinicaliQ Trial Snapshot
  • A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity — Active Not Recruiting • Phase II • Diabetes / Metabolic •….
  • A new drug combined with tirzepatide tested against tirzepatide alone for weight loss in overweight or obese adults over 48 weeks.

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What This Trial Is Studying

The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants…

Full Trial Details
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Eligibility criteria, protocol, and results when available
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Related Clinical Intelligence

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

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…
View guideline →
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
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…
View guideline →
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
Weight-loss jabs will be offered on NHS for people at risk of further heart attacks
Cardiology / Cardiovascular · BBC Health · 31 Mar 2026
GLP-1 receptor agonists (weight-loss jabs) will now be offered on NHS to over 1 million people in England at high cardiovascular risk,…
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Clinical Brief
New light shed on who benefits most from weight-loss jabs
Diabetes / Metabolic · BBC Health · 08 Apr 2026
People who carry variations in two genes linked to appetite and digestion can lose more weight when taking drugs to treat obesity,…
View brief →