RO7204239
DrugRO7204239 or matching placebo will be administered as per the schedule specified in the arms.
NCT Number: NCT06965413
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 will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
Centrum Medyczne ALL-MED, Krakow, Lesser Poland Voivodeship, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RO7204239 or matching placebo will be administered as per the schedule specified in the arms.
RO7204239 matching placebo will be administered as per the schedule specified in the arm.
Tirzepatide will be administered as per the schedule specified in the arms.
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Time frame: Baseline, Week 48
Fasting lipid profile includes total cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), non-HDL cholesterol
Time frame: Up to approximately 100 weeks
Time frame: Up to approximately 100 weeks
Time frame: Up to approximately 96 weeks
Time frame: Up to approximately 96 weeks
Time frame: Up to approximately 96 weeks
Time frame: Up to approximately 96 weeks
Time frame: Up to approximately 96 weeks
Time frame: Up to approximately 96 weeks
Time frame: Up to approximately 96 weeks
Time frame: Up to approximately 96 weeks
Hoffmann-La Roche
Industry
A Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Assess Efficacy, Safety, and Tolerability of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity
Acronym: GYMINDA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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