Actively Recruiting
A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults
Led by Shanghai World Leader Pharmaceutical Co., Ltd. · Updated on 2026-03-12
60
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 years and up to 65 years
- Body Mass Index (BMI) between 27.0 and 35.0 kg/m² at screening
- Weight stable within ±5% during the 3 months before screening using diet and exercise alone
- Agreement to use effective contraception and no plans for conception during the study and 3 months after last dose
- Negative anti-HIV antibody test at screening
- Ability to understand the study 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 genetic or medical conditions such as hypothalamic or pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism
- History of bariatric surgery or plans for bariatric surgery during the study
- Use of anti-obesity medications, GLP-1 receptor agonists, antidiabetic drugs, or other weight-affecting treatments within 3 months prior to screening
- Use of investigational drugs, vaccines, or medical devices
- Laboratory abnormalities including high HbA1c, uncontrolled hypertension, abnormal thyroid function, liver enzyme elevation, high triglycerides, abnormal amylase or lipase, elevated calcitonin, low kidney function, or significant ECG abnormalities
- History of pancreatitis or symptomatic gallbladder disease
- Nasal conditions or recent nasal surgery or trauma affecting drug administration
- Extensive scars or large tattoos on abdomen, thighs, or upper arms
- History of thyroid disease requiring treatment
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Any malignancy diagnosed within 5 years except certain cured cancers
- Recent major cardiovascular or cerebrovascular events or severe heart failure
- Significant gastrointestinal diseases
- Positive tests for hepatitis B, hepatitis C, or syphilis
- Recent upper respiratory tract infection
- Major depressive disorder or severe psychiatric illness within 2 years, history of self-harm or suicidal behavior
- Recent blood donation or total blood loss exceeding 400 mL
- History of vasovagal syncope or intolerance to blood draws
- Allergic reactions to GLP-1 receptor agonists or study drug ingredients
- History of alcohol abuse or unwillingness to abstain during study
- Smoking more than 5 cigarettes per day or unwillingness to abstain during study
- History of substance abuse or positive drug screening
- Pregnancy, breastfeeding, or positive pregnancy tests at screening
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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