A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic (PK) of Single-dose Administration of Semaglutide Nasal Spray (WL1006) in Adult Overweight or Obese Participants

Registration

Registration

NCT07465965

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

QUADRUPLE

Status

RECRUITING

Enrollment

60

Start

2026-03-02

Primary completion

2026-08-21

Lead sponsor

Shanghai World Leader Pharmaceutical Co., Ltd.

Conditions

Overweight; Obesity

Interventions

DRUG:Semaglutide Nasal Spray; DRUG:Placebo; DRUG:Semaglutide Injection

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• Maximum Plasma Concentration (Cmax) [Day 1 to Day 36 after administration]
• Time to maximum concentration(Tmax) [Day 1 to Day 36 after administration]
• Area under the concentration-time curve from time 0 to time t (AUC0-t) [Day 1 to Day 36 after administration]
• Area under the concentration-time curve from time 0 to infinity(AUC0-∞) [Day 1 to Day 36 after administration]
• Percentage of AUC extrapolated(AUC%Extrap) [Day 1 to Day 36 after administration]
• Elimination half-life / Terminal half-life(t1/2) [Day 1 to Day 36 after administration]
• Apparent volume of distribution during terminal phase, adjusted for bioavailability (Vz/F) [Day 1 to Day 36 after administration]
• Apparent clearance, adjusted for bioavailability(CL/F) [Day 1 to Day 36 after administration]
• Terminal elimination rate constant(λz) [Day 1 to Day 36 after administration]
• Absolute bioavailability(F) [Day 1 to Day 36 after administration]
• Incidence and severity of treatment emergent adverse events (TEAEs) [Day 1 to Day 36 after administration]
• 12-Lead-ECGs(Electrocardiograms ) [Day 1 to Day 36 after administration]
• Temperature [Day 1 to Day 36 after administration]
• Pulse [Day 1 to Day 36 after administration]
• Respiratory rate [Day 1 to Day 36 after administration]
• Blood pressure [Day 1 to Day 36 after administration]
• Urinalysis [Day 1 to Day 36 after administration]
• Blood biochemistry [Day 1 to Day 36 after administration]
• Thyroid function [Day 1 to Day 36 after administration]
• Virology test [Day 1 to Day 36 after administration]
• Urine pregnancy test [Day 1 to Day 36 after administration]
• Physical examination, includes: head, ears, eyes, nose and throat, skin, lymph nodes, neck, chest, abdomen, heart, cardiovascular, musculoskeletal system/extremities, neurological system and body weight. [Day 1 to Day 4 after administration]
• Hemoglobin [Day 1 to Day 36 after administration]
• Hematocrit [Day 1 to Day 36 after administration]
• Red blood cell count [Day 1 to day 36]
• White blood cell count [Day 1 to day36]
• Platelet count [Day 1 to day 36]
• Neutrophil percentage [day 1 to day 36]
• Eosinophil percentage [day 1 to day 36]
• Basophil percentage [day 1 to day 36]
• Monocyte percentage [day 1 to day 36]
• Lymphocyte percentage [day 1 to day 36]
• Activated partial thromboplastin time [Day 1 to day 36]
• Prothrombin time [day 1 to day 36]
• Fibrinogen [day 1 to day 36]
• Thrombin time [day 1 to day 36]