Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo
NCT06577090 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2026-01-14
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Skye Bioscience, Inc.
lead INDUSTRY
Principal Investigators
-
Chief Development Officer · Skye Bioscience, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-22
- Primary Completion
- 2026-11-20
- Completion
- 2027-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
NCT05616013 ·Status: COMPLETED ·Phase: PHASE2
-
Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
NCT03693430 ·Status: COMPLETED ·Phase: PHASE3
-
Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.
NCT04251156 ·Status: COMPLETED ·Phase: PHASE3
-
Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
NCT05040971 ·Status: COMPLETED ·Phase: PHASE3
-
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
NCT03548987 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
NCT07284979 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes
NCT05950516 ·Status: UNKNOWN ·Phase: PHASE3
-
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
NCT03600480 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a Glucagon-like Peptide-1 (GLP-1) Agonist
NCT06500429 ·Status: COMPLETED ·Phase: PHASE2
-
Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
NCT03611582 ·Status: COMPLETED ·Phase: PHASE3
-
Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
NCT04074161 ·Status: COMPLETED ·Phase: PHASE3
-
A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
NCT05486065 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Semaglutide Injection (HD1916) in Patients With Type 2 Diabetes Mellitus
NCT06161844 ·Status: COMPLETED ·Phase: PHASE3
-
A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes
NCT04109547 ·Status: COMPLETED ·Phase: PHASE3
-
Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
NCT02963922 ·Status: COMPLETED ·Phase: PHASE3
-
Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects
NCT05548647 ·Status: COMPLETED ·Phase: PHASE4
-
STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
NCT03548935 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
NCT06565611 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity
NCT05444153 ·Status: WITHDRAWN ·Phase: PHASE3
-
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
NCT05564117 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
NCT06047548 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
NCT03486392 ·Status: COMPLETED ·Phase: PHASE2
-
STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
NCT03811574 ·Status: COMPLETED ·Phase: PHASE3
-
A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet
NCT05429593 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
NCT02863419 ·Status: COMPLETED ·Phase: PHASE3