NCT06577090

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

A Phase 2 Study of QW Nimacimab Injection, Compared to Placebo Injection and QW Weekly Nimacimab Injection Co-administered With Semaglutide in Participants Who Are Overweight or Obese

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Skye Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a proof-of-concept study to assess the safety and efficacy of Nimacimab Injection compared to an active and placebo injection control.

Detailed description

The purpose of this study is to measure the change in body weight with once weekly doses of Nimacimab Injection compared with placebo injection and once weekly Nimacimab Injection co-administered with commercially available semaglutide injection (Wegovy®) in participants with obesity or are overweight with weight-related comorbidities. A study extension has been added to include additional 26 weeks of treatment and 13 weeks of follow up for qualifying participants starting May2025.

Conditions

• Obesity

Interventions

Type	Name	Description
BIOLOGICAL	Nimacimab injection	Nimacimab injection 200 mg
BIOLOGICAL	Nimacimab placebo injection	matching nimacimab placebo injection
COMBINATION_PRODUCT	semaglutide injection	semaglutide injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg + nimacimab 200 mg
BIOLOGICAL	Nimacimab 300 mg injection	Nimacimab injection 300 mg

Timeline

• Start date: 2024-08-22
• Primary completion: 2026-11-20
• Completion: 2027-02-28
• First posted: 2024-08-29
• Last updated: 2026-01-14

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study