Low-Dose Semaglutide for Weight Loss in Obese Non-Diabetic Pakistani Adults

Status

Recruiting

Phase

Phase 4

Enrollment

60 participants (estimated)

Sponsor

Asian Institute Of Medical Sciences · Other

Design

Allocation not applicable · Open label (no masking)

Countries

1 country

Pakistan

Start

1 Aug 2025

Primary completion

30 Aug 2026 (estimated)

Completion

1 Dec 2026 (estimated)

First posted

6 Apr 2026

Last update posted

6 Apr 2026

Conditions

Obesity · Weight Reduction · Cardiometabolic Risk Factors

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.

• Experimental

  Low-Dose Semaglutide Intervention

  Participants in this single arm will receive once-weekly subcutaneous injections of locally available semaglutide (rDNA-based) for a total duration of 24 weeks (6 months). The intervention follows a standardized dose titration schedule to improve tolerability and minimize gastrointestinal adverse effects. All participants will receive standardized lifestyle counseling at baseline, month 3, and month 6, including guidance on a balanced hypocaloric diet (500-750 kcal/day deficit) and encouragement of moderate-intensity physical activity (≥150 minutes per week). No comparator or placebo arm is included in this single-arm design.

1. Percentage Change in Body Weight

   Time frame · Baseline to 24 weeks

   Registry description

   The primary outcome is the percentage change in body weight from baseline to 24 weeks following once-weekly low-dose semaglutide treatment. Body weight will be measured using standardized calibrated scales at baseline, 12 weeks, and 24 weeks. The outcome will assess the efficacy of semaglutide in reducing weight in obese adults without type 2 diabetes mellitus.