Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Single-dose Semaglutide Nasal Spray in Adult Overweight or Obese Participants
Led by Shanghai World Leader Pharmaceutical Co., Ltd. · Updated on 2026-03-12
60
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.
CONDITIONS
Brief Title
A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 65 years
- Body Mass Index (BMI) between 27.0 and 35.0 kg/m² at screening
- Weight change of no more than ±5% during the 3 months before screening with diet and exercise alone
- Agreement to use effective contraception and no plans for conception during the study and for 3 months after last dose
- Negative anti-HIV antibody test at screening
- Ability to understand the study, communicate well, comply with requirements, and provide informed consent
You will not qualify if you...
- Diagnosis of type 1, type 2, or other forms of diabetes mellitus
- Obesity caused by monogenic mutations or certain medical conditions like hypothyroidism or Cushing's syndrome
- Prior bariatric surgery or plans for bariatric surgery or weight-loss devices during the study
- Use of anti-obesity drugs, GLP-1 receptor agonists, antidiabetic medications, or other treatments affecting weight within 3 months prior to screening
- Use of investigational drugs, vaccines, or medical devices
- Laboratory abnormalities including high HbA1c, uncontrolled hypertension, abnormal thyroid function, elevated liver enzymes, triglycerides, amylase or lipase, calcitonin, low kidney function, or significant ECG findings
- History of pancreatitis, symptomatic gallbladder disease, or significant nasal conditions affecting drug delivery
- Recent nasal surgery or trauma not fully healed
- Extensive scars or tattoos on administration sites
- History or family history of certain thyroid cancers or multiple endocrine neoplasia
- Recent malignancy except specified cured cancers
- Recent major cardiovascular or cerebrovascular events or heart failure class III-IV
- Significant gastrointestinal diseases
- Positive tests for hepatitis B, hepatitis C, or syphilis
- Recent upper respiratory tract infection
- Recent severe psychiatric illness or suicidal ideation
- Recent blood donation or major blood loss
- History of syncope or intolerance to blood draws
- Allergy to GLP-1 receptor agonists or study drug components
- Recent alcohol abuse or unwillingness to abstain during study
- Smoking more than 5 cigarettes per day or unwillingness to abstain
- Recent substance abuse or positive drug screening
- Pregnancy, breastfeeding, or positive pregnancy tests
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of semaglutide nasal spray, semaglutide injection, or placebo to evaluate safety, tolerability, and pharmacokinetics.
1 treatment visit (in-person)
Duration - Up to 36 days after treatment
Participants are monitored for safety and pharmacokinetic outcomes following the single-dose administration.
Multiple follow-up visits up to Day 36
Trial Site Locations
Total: 1 location
1
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States, 07094
Actively Recruiting
Research Team
G
Guiyi Huang, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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