Study to evaluate the effectiveness and safety of Spartina® (Tirzepatide manufactured by CinnaGen Co.) in adolescents with obesity and weight-related comorbidities
The objectives of this study are to assess the effectiveness and safety of Spartina® in adolescents with obesity.
Design
Prospective, Interventional
Settings and conduct
This study will be conducted on 65 adolescents with obesity and at least one weight-related comorbidity who are candidates for treatment with Spartina® over 24 weeks. During this period, patients will have 8 visits. At each visit, the effectiveness of Spartina® will be evaluated with the changes in BMI, weight, and waist circumference. Furthermore, the effectiveness of Spartina® will be assessed by the percentage of patients achieving ≥ 5%, ≥10%, and ≥15% reduction of BMI. Also, at each visit, participants will be evaluated and asked about the occurrence of adverse events after starting Spartina® by their physicians.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1.Age between 12 and <18 years 2. Have obesity, with at least one weight-related comorbidity 3.Capable of giving informed consent by a legal representative and assent by a study participant
Exclusion criteria:
1.Prior use of any GLP-1 agonist in the last 6 months 2.Any condition or circumstance that, according to the investigator, might pose a risk to the subject if they are enrolled or interfere with the ability to acquire satisfactory clinical data 3.Having undergone or planning to undergo a weight reduction procedure 4.Pregnancy or breastfeeding 5.Prepubertal stage 6.Personal or family history MTC or patients with MEN 2 7.Have T1DM
Intervention groups
Tirzepatide (2.5–15 mg once weekly); the weekly dose should be increased to 5 mg after the first month, if the dose escalation is tolerable for the participant. Any further increase in the weekly dose for each individual is based on the investigator’s opinion.
Main outcome variables
Weight
BMI
WC
Dose of Spartina®
Adverse events
Hip circumference
Neck circumference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N45
Registration date:2026-10-08, 1405/07/16
Registration timing:prospective
Last update:2026-10-08, 1405/07/16
Update count:0
Registration date
2026-10-08, 1405/07/16
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-22, 1405/07/30
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study to evaluate the effectiveness and safety of Spartina® (Tirzepatide manufactured by CinnaGen Co.) in adolescents with obesity and weight-related comorbidities
Public title
Study to evaluate Spartina® (Tirzepatide manufactured by CinnaGen Co.) in adolescents with obesity and weight-related comorbidities
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female between 12 and <18 years of age
Obesity, defined as BMI ≥ 95th percentile for age and sex (on age- and gender-specific growth chart for diagnosis of obesity) ORHave overweight, as defined by BMI ≥ 85th percentile but < 95th percentile for age and sex, on age- and sex-specific growth chart, with at least one weight-related comorbidity, including but not limited to: 1.Dyslipidemia 2.Prehypertension/Hypertension 3.Metabolic dysfunction-associated steatotic liver disease 4.Obstructive sleep apnea 5.Prediabetes 6.Type 2 Diabetes Mellitus (T2DM) with an HbA1C < 9% 7.Polyendocrine metabolic ovarian syndrome
Capable of giving informed consent by a legal representative and assent by a study participant (when applicable)
Exclusion criteria:
Prior use of any GLP-1 agonist in the last 6 months
Having undergone or planning to undergo a weight reduction procedure, such as, but not limited to: a.Gastric bypass b.Sleeve gastrectomy c.Restrictive bariatric surgeries d.Any other procedure intended to result in weight reduction
Pregnancy or breastfeeding
Prepubertal stage (Tanner stage 1)
Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
Have type 1 diabetes mellitus
Any condition or circumstance that, according to the investigator, might pose a risk to the subject if they are enrolled or interfere with the ability to acquire satisfactory clinical data
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences Ethics Committee
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2026-10-03, 1405/07/11
Ethics committee reference number
IR.IUMS.REC.1405.394
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Change in body mass index (BMI) standard deviation score (Z-score) from baseline until week 24
Measuring height with a stadiometer, rounded to the nearest centimeterMeasuring weight with a scaleBMI = weight (Kg)/ Height (m2)Z-score will be calculated based on the LMS tables provided by WHO.
Secondary outcomes
1
Description
•Percentage of participants who achieve BMI reduction of ≥ 5% from baseline until week 12
Adverse events occurred during the study based on physician assessment
Intervention groups
1
Description
Intervention group: Pre-filled syringes of Spartina® (Tirzepatide manufactured by CinnaGen Co.) will be prescribed and injected subcutaneously once a week with a dose starting from 2.5 mg/weekly and titrated up based on the physician’s opinion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Children's Hospital
Full name of responsible person
Dr. Fahimeh Soheilipour
Street address
Tehran, Modares Highway (North), Shahid Vahid Dastgerdi Street (formerly Zafer), No. 193.
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۳
Phone
+98 912 945 2311
Email
fsoheilipour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CinnaGen Company
Full name of responsible person
Mehran Montajabi Niyat
Street address
Alborz Province, Fardis County, Simin Dasht Industrial Town, 9th Western Street, No. 72, Ground Floor.
City
Tehran
Province
Tehran
Postal code
3165933155
Phone
+98 21 4291 5000
Email
info@cinnagen.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CinnaGen Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Orchid Pharmed
Full name of responsible person
Dr. Hamidreza Kafi
Position
Medical Manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 42, Attar Neyshaboori St., Vanak Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Fax
+98 21 8856 2862
Email
Kafi.H@orchidpharmed.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Fahimeh Soheilipour
Position
Professor of Pediatric Endocrinology & Metabolism
Latest degree
Medical doctor
Other areas of specialty/work
Professor of Pediatric Endocrinology & Metabolism
Street address
Tehran, Modares Highway (North), Shahid Vahid Dastgerdi Street (formerly Zafer), No. 193.