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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The specific aim of this study is to examine the Safety, Tolerability and Pharmacokinetic of Semaglutide Nasal Spray compared with placebo and positive control in Adult Overweight or Obese Participants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Male or female participants aged ≥18 years and ≤ 65 years.

• Body Mass Index (BMI) at screening between 27.0 and 35.0 kg/m² (inclusive).

• Weight change of no more than ±5% during the 3 months prior to screening with diet and exercise alone (self-reported).

• Participants (including males) must have no plans for conception during the study and within 3 months after the last administration, and must agree to use effective contraceptive methods and refrain from donating sperm or eggs during this period.

• Negative anti-HIV antibody test result at screening.

• Participants must fully understand the trial objectives, nature, procedures, and potential adverse reactions, voluntarily participate, be able to communicate well with the investigators, comply with all study requirements, and sign the informed consent form before any study procedures begin.

Locations
United States
New Jersey
Frontage Clinical Services, Inc.
RECRUITING
Secaucus
Contact Information
Primary
Guiyi Huang, Master
huangguiyi@worldleadertdds.com
0086-18640027113
Time Frame
Start Date: 2026-03-02
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 60
Treatments
Experimental: Cohort A0 : Semaglutide Nasal Spray
Experimental: Cohort A1: Semaglutide nasal spray and placebo
Experimental: Cohort A2:Semaglutide nasal spray and placebo
Active_comparator: Cohort A3: Semaglutide injection
Related Therapeutic Areas
Sponsors
Leads: Shanghai World Leader Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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