Low-dose semaglutide for weight loss in obese Pakistani adults

Efficacy and Safety of Low-Dose Semaglutide for Weight Loss and Cardiometabolic Improvement in Obese Pakistani Adults Without Type 2 Diabetes: A Single-Arm Open-Label Single-Center Trial

This study will see if once-weekly low-dose semaglutide plus lifestyle counseling helps obese Pakistani adults without diabetes lose weight over 24 weeks.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Asian Institute Of Medical Sciences (other)
• Locations: 1 site (Hyderābād, Sindh)
• Trial ID: NCT07513168 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm pilot interventional study will enroll 60 obese Pakistani adults without type 2 diabetes at a single center in Hyderabad. Participants will receive once-weekly subcutaneous semaglutide with stepwise titration (0.25 mg for 4 weeks, 0.5 mg for 4 weeks, then 1.0 mg for 16 weeks) alongside standardized hypocaloric diet and lifestyle counseling for a total of 24 weeks. Primary outcomes include weight loss and changes in cardiometabolic risk factors, with safety monitored through laboratory testing and adverse event reporting. The trial aims to generate locally relevant data on the effectiveness and tolerability of lower-dose semaglutide in a South Asian, non-diabetic population.

Who should consider this trial

Good fit: Adults aged 18 years or older with BMI ≥27.5 kg/m² (WHO Asian cutoff), without type 2 diabetes, who can self-administer weekly injections and attend visits in Hyderabad are ideal candidates.

Not a fit: Patients with type 2 diabetes, pregnancy or lactation, history of pancreatitis or medullary thyroid carcinoma/MEN2, severe renal or hepatic impairment, or current use of other anti-obesity medications are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this regimen could help patients achieve meaningful weight loss and improve cardiometabolic risk factors using a locally available lower-dose semaglutide formulation.

How similar studies have performed: Higher-dose semaglutide has produced substantial weight loss and cardiometabolic benefits in international trials, but the effectiveness and safety of lower-dose formulations in non-diabetic South Asian populations are less well studied.

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.

Where this trial is running

Hyderābād, Sindh

• Asian Institute of Medical Sciences — Hyderābād, Sindh, Pakistan (RECRUITING)

Study contacts

• Principal investigator: Sadik Memon — Asian Institute Of Medical Sciences
• Study coordinator: Fatima Nadeem Dr, Pharm-D, Mphil

Conditions: Obesity, Weight Reduction, Cardiometabolic Risk Factors, Semaglutide, Weight loss, GLP-1 Receptor Agonist, Body Mass Index, Open label trial