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CBeyondNCT06577090

Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 11 versions: 11 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 51 wordsv11 Show 6 more changesShow less
    • Primary endpoints: 3 to 2
    • Enrollment target: estimated 152 to confirmed 136
    • Interventions: Nimacimab 300 mg injection (Biological), Nimacimab Infusion (Biological), Nimacimab injection (Biological), Nimacimab placebo injection… to Nimacimab 300 mg injection (Biological), Nimacimab injection (Biological), Nimacimab placebo injection (Biological), semaglutide injection…
    • Secondary endpoints: 11 to 9
    • Study description shortened, about 38 words
    • Study arms: 6 to 5
  2. Primary completion date: Aug 2025 to Nov 20, 2026v10 Show 9 more changesShow less
    • Eligibility criteria expanded, about 185 words
    • Primary endpoints: 1 to 3
    • Enrollment target: 120 to 152
    • Study completion date: Jan 2026 to Feb 28, 2027
    • Interventions: Nimacimab injection (Biological), Nimacimab placebo injection (Biological), semaglutide injection (Combination Product) to Nimacimab 300 mg injection (Biological), Nimacimab Infusion (Biological), Nimacimab injection (Biological), Nimacimab placebo injection…
    • Secondary endpoints: 5 to 11
    • Study description expanded, about 62 words
    • Study arms: 4 to 6
    • Study title shortened, about 5 words
  3. Eligibility criteria expanded, about 142 wordsv9 Show 4 more changesShow less
    • Primary endpoints: 2 to 1
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 18 to 16
    • Secondary endpoints: 2 to 5
  4. Site details revised at 7 of 18 sitesv8
  5. Site details revised at 3 of 18 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 2 of 18 sitesv6
  2. Site details revised at 1 of 18 sitesv5
  3. Site details revised at 1 of 18 sitesv4
  4. Study sites: 4 to 18v3
  5. Study sites: 1 to 4
    • Study completion date: Nov 2025 to Jan 2026
    • Start date changed from estimate of Aug 21, 2024 to Aug 22, 2024
    • Collaborators shortened, about 5 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percent change in body weight (main study)
Timeframe: From Baseline to Week 26
Nature, frequency and severity of AEs (study extension)
Timeframe: Baseline through Week 38 of study extension (approximately 10 months of participation)

Secondary (9)

Change in body weight (main study)
Change in waist circumference (main study)
Change in waist circumference (study extension)
Change in lean versus fat mass ratio measured by DXA (main study)
Change in lean versus fat mass ratio measured by DXA (study extension)
Show 4 moreShow less
Change in BMI (main study)
Change in BMI (study extension)
Percent of participants with greater than/equal to 5% body weight reduction as well as greater than/equal to 10% body weight reduction (main study)
Percent change in body weight (kg) (study extension)

Arms and interventions

Nimacimab injectionExperimental

Nimacimab injection 200 mg

Nimacimab placebo injectionPlacebo comparator

Matching nimacimab placebo injection

Semaglutide injection + Nimacimab injection 200 mgExperimental

Semaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg

Semaglutide injection + Nimacimab placebo injectionActive comparator

Semaglutide injection administered according to dose escalation described in semaglutide Prescribing Information plus concomitant administration of Nimacimab Injection or matching placebo injection

Open-label 300 mg Nimacimab injection (study extension)Experimental

Weekly nimacimab injection 300 mg open-label (study extension)

Biologicals: Nimacimab injection, Nimacimab placebo injection, Nimacimab 300 mg injection

Combination products: semaglutide injection

Sites

16 sites in 1 country