Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT07465965

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Frontage Clinical Services, Inc.

Secaucus, New Jersey, United States, 07094

Actively Recruiting

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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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