The objectives of this study are to assess effectiveness, and safety of Spartina®
Design
Before-after, single-armed, prospective study
Settings and conduct
A post-marketing real-world study for evaluating effectiveness and safety of Spartina® (Tirzepatide manufactured by CinnaGen Co.) in patients with prediabetes and obesity or overweight with weekly injection
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1.Male or female ≥18 years of age
2.BMI ≥ 27 or WC ≥ 94 cm (Men) / ≥ 80 cm (Women).
3.Willingness for signing and having signed the informed consent form
4.Confirmed prediabetes diagnosis (100 ≤ FBS ≤ 125 OR 5.6 ≤ HbA1C ≤ 6.4 OR 140 ≤ 2hPP ≤ 199)
Exclusion criteria:
1.Prior use of any GLP-1 agonist in the last 6 months
2.Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data (e.g. acute pancreatitis/suspicious for pancreatitis, acute cholecystic disorders, severe hypoglycemia, hypersensitivity to the drug class, severe or sustain gastroenteric adverse events (grade3 or higher))
3.Pregnancy or breast-feeding
4.Personal or family history of MTC or patients with MEN 2 syndrome
5.Diabetes diagnosis
Intervention groups
Tirzepatide (2.5–7.5 mg once weekly), dose should be increased to 5 mg after the first month in case of good tolerability
Main outcome variables
Waist circumference (WC)
Body mass index (BMI)
Weight
Blood pressure
FBS
HbA1C
HOMA-IR
ASCVD
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N42
Registration date:2026-05-20, 1405/02/30
Registration timing:registered_while_recruiting
Last update:2026-05-20, 1405/02/30
Update count:0
Registration date
2026-05-20, 1405/02/30
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
Recruitment complete
Funding source
Expected recruitment start date
2026-04-21, 1405/02/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness and safety of Spartina® (Tirzepatide manufactured by CinnaGen) in patients with prediabetes and overweight or obesity
Public title
Before-after study of Spartina® (CinnaGen Co.)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female ≥18 years of age
Body mass index (BMI) ≥ 27 or waist circumference (WC) ≥ 94 cm (Men) / ≥ 80 cm (Women).
Willingness for signing and having signed the informed consent form
Confirmed prediabetes diagnosis (100 ≤ Fasting blood sugar (FBS) ≤ 125 OR 5.6 ≤ HbA1C ≤ 6.4 OR 140 ≤ 2-hours post prandial glucose ≤ 199)
Exclusion criteria:
Prior use of any glucagon-like peptide-1 (GLP -1) agonist in the last 6 months
Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data (e.g. acute pancreatitis/suspicious for pancreatitis, acute cholecystic disorders, severe hypoglycemia, hypersensitivity to the drug class, severe or sustain gastroenteric adverse events )grade 3 or higher))
Pregnancy or breast-feeding
Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
Diabetes diagnosis
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran, Chamran Highway, Evin, next to Taleghani Hospital, Building No. 2, Deputy of Research and Technology
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۹۴۱۱
Approval date
2026-04-18, 1405/01/29
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1405.014
Health conditions studied
1
Description of health condition studied
Prediabetes and overweight or obesity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean of fasting blood sugar (FBS) at day 90
Timepoint
Day 90
Method of measurement
Laboratory test
Secondary outcomes
1
Description
Mean change from baseline in FBS at day 90
Timepoint
Day 0, Day 90
Method of measurement
Laboratory test
2
Description
Proportion of patients with equal to or more than 5% weight loss at day 90
Timepoint
Day 0, Day 90
Method of measurement
Weighting with scale
3
Description
Percent change in body weight from baseline till day 90
Timepoint
Day 0, Day 90
Method of measurement
Weighting with scale
4
Description
Absolute change in body weight from baseline till day 90
Timepoint
Day 0, Day 90
Method of measurement
Weighting with scale
5
Description
Mean change from baseline in body mass index (BMI) at day 90
Timepoint
Day 0, Day 90
Method of measurement
Division of weight by square of height
6
Description
Mean change from baseline in waist circumference (WC) at day 90
Timepoint
Day 0, Day 90
Method of measurement
Measurement by tape
7
Description
Mean change from baseline in systolic blood pressure at day 90
Timepoint
Day 0, Day 90
Method of measurement
Using Sphygmomanometer
8
Description
Mean change from baseline in diastolic blood pressure at day 90
Timepoint
Day 0, Day 90
Method of measurement
Using Sphygmomanometer
9
Description
Proportion of patients achieving normoglycemia at day 90
Timepoint
Day 90
Method of measurement
Lab oratory test
10
Description
Mean change from baseline in HbA1C at day 90
Timepoint
Day 0, Day 90
Method of measurement
Lab oratory test
11
Description
Mean change from baseline in homeostatic model assessment for insulin resistance (HOMA-IR) index at day 90
Timepoint
Day 0, Day 90
Method of measurement
Using HOMA-IR formula
12
Description
Mean change from baseline in 10-years atherosclerotic cardiovascular disease (ASCVD ) risk at day 90
Timepoint
Day 0, Day 90
Method of measurement
Using 10-years ASCVD formula
Intervention groups
1
Description
Intervention group: Tirzepatide (2.5–7.5 mg once weekly), dose should be increased to 5 mg after the first month in case of good tolerability
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University
Full name of responsible person
Dr. Jalaledin Mirzay Razaz
Street address
Tehran, Quds town (the West) Shahid Farahzadi Boulevard, Shahid Hafezi Street (Western purple) Plaque 7
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
Jmrazaz@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CinnaGen Company
Full name of responsible person
Mehran Montajabi Niyat
Street address
Simin Dasht Industrial Park, Karaj, Alborz, Iran
City
Karaj
Province
Tehran
Postal code
3165933155
Phone
+98 26 3667 0334
Email
info@cinnagen.com
Web page address
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 Co.
Full name of responsible person
Dr. Hamidreza Kafi
Position
Medical Department Manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 42, Attar St., Vanak Sq
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
Kafi.H@orchidpharmed.com
Web page address
https://orchidpharmed.com/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Jalaledin Mirzay Razaz
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran, Quds town (the West) Shahid Farahzadi Boulevard, Shahid Hafezi Street (Western purple) Plaque 7