NCT07513168 Low-Dose Semaglutide for Weight Loss in Obese Non-Diabetic Pakistani Adults
| NCT ID | NCT07513168 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Asian Institute Of Medical Sciences |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-08-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective, open-label, single-arm, single-center interventional pilot trial aims to evaluate the efficacy and safety of low-dose semaglutide for weight loss and cardiometabolic improvement in obese Pakistani adults without type 2 diabetes mellitus. The study will be conducted at the Asian Institute of Medical Sciences (AIMS), Hyderabad, Sindh, Pakistan. A total of 60 obese adults aged 18 years or older with a body mass index (BMI) of 27.5 kg/m² or greater according to World Health Organization Asian cutoffs and without type 2 diabetes mellitus (fasting blood glucose \<126 mg/dL and HbA1c \<6.5%) will be enrolled. Eligible participants will receive once-weekly subcutaneous semaglutide following a standard dose titration schedule of 0.25 mg weekly for four weeks, 0.5 mg weekly for four weeks, and 1.0 mg weekly for the remaining 16 weeks, for a total treatment duration of 24 weeks. All participants will receive standardized lifestyle counseling, including a hypocaloric diet with a 500-750 kcal/day deficit and at least 150 minutes per week of moderate-intensity physical activity. The primary outcome is the percentage change in body weight from baseline to 24 weeks. Secondary outcomes include changes in body mass index, waist circumference, systolic and diastolic blood pressure, lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides), liver enzymes (alanine aminotransferase and aspartate aminotransferase), and quality of life. Safety will be assessed through continuous monitoring of adverse events and adverse drug reactions with causality assessment using the Naranjo Adverse Drug Reaction Probability Scale. Clinical and laboratory assessments will be conducted at baseline, 12 weeks, and 24 weeks. Data will be analyzed using descriptive and inferential statistics, including paired t-tests or non-parametric equivalents and repeated measures analysis, with a significance level of p \< 0.05. The study will be conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki, with approval from the AIMS Institutional Review Board and written informed consent obtained from all participants. The trial aims to generate locally relevant clinical evidence on the effectiveness and safety of low-dose semaglutide for obesity management in non-diabetic Pakistani adults.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or older. * Body mass index (BMI ≥ 27.5 kg/m²) according to WHO Asian cut-offs. * No diagnosis of type 2 diabetes mellitus, confirmed by: Fasting blood glucose \< 126 mg/dL, and HbA1c \< 6.5% within three months prior to enrollment. * Willingness and ability to provide written informed consent. * Willingness to comply with study procedures, including weekly injections and lifestyle counseling. Exclusion Criteria: * History of pancreatitis. * History or presence of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2). * Pregnant or lactating women. * Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or hepatic impairment (ALT or AST \> 3× upper limit of normal). * Current use of other anti-obesity medications. * Known hypersensitivity to semaglutide or any component of the formulation. * Any condition that, in the investigator's opinion, would interfere with participation, adherence, or safety in the study.
Contact & Investigator
Dr. Fatima Nadeem
STUDY DIRECTOR
Asian Institute Of Medical Sciences
Frequently Asked Questions
Who can join the NCT07513168 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07513168 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07513168 currently recruiting?
Yes, NCT07513168 is actively recruiting participants. Contact the research team at fatima.nadeem2401@gmail.com for enrollment information.
Where is the NCT07513168 trial being conducted?
This trial is being conducted at Hyderābād, Pakistan.
Who is sponsoring the NCT07513168 clinical trial?
NCT07513168 is sponsored by Asian Institute Of Medical Sciences. The principal investigator is Dr. Fatima Nadeem at Asian Institute Of Medical Sciences. The trial plans to enroll 60 participants.
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