ObesityPhase 3SURMOUNT-CNNCT05024032
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
A Phase 3 study testing Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 29 sites in China.
Trial summary
This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight. The main purpose is to learn more about how tirzepatide affects body weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight, Metabolism and Nutrition Disorder
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 29 sitesChina
- Study dates
- 1 Sep 2021to 27 Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
Who cannot join
- Have Diabetes Mellitus
- Have a self-reported change in body weight >5 kg within 3 months prior to screening
- Have obesity induced by other endocrinological disorders
- Have had a history of chronic or acute pancreatitis
- Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years
- Have any lifetime history of a suicide attempt
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102202
The Second Hospital of Jilin University
Changchun, Jilin
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213000
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Zhujiang Hospital
Guangzhou, Guangdong, 510280
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, 421001
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Jinan Central Hospital
Jinan, Shandong, 250013
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Ningbo First Hospital
Ningbo, Zhejiang, 315010
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071
Qingpu Branch of Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 201700
The Fifth People's Hospital of Shanghai
Shanghai, 200240
Shanghai Minhang District Central Hospital
Shanghai, 201199
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518039
Siping Central People's Hospital
Siping, Jilin, 136000
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710077
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
About this study
Official title: Efficacy and Safety of Tirzepatide Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-CN)
This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight.
The main purpose is to learn more about how tirzepatide affects body weight.
- Conditions
- Obesity, Overweight, Metabolism and Nutrition Disorder
- Being tested
- Tirzepatide, Placebo
- Medical subject headings
- Obesity, Overweight, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 10 Milligrams (mg) Tirzepatide | Experimental | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW). Receives: Drug: Tirzepatide |
| 15 mg Tirzepatide | Experimental | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants received matching placebo SC QW. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline in Body Weight
Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.
Measured: Week 52
Secondary outcomes (19)
Mean Change From Baseline in Body Weight
Mean Change from Baseline in Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 20
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis.
Measured: Week 52
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis.
Measured: Week 52
Mean Change From Baseline in Waist Circumference
Mean Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Absolute Body Weight
Mean Change from Baseline in Absolute Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Body Mass Index (BMI)
Mean Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Hemoglobin A1c (HbA1c)
Mean Change from Baseline in HbA1c. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Fasting Glucose (FSG)
Mean Change from Baseline in FSG. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary.
Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model with Variable = Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual measurement/Baseline) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model with log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Sep 2021
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024032
- Sponsor's protocol ID
- 17507
- Other IDs
- I8F-MC-GPIA
- Acronym
- SURMOUNT-CN
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2021
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Zhao L, Cheng Z, Lu Y, Liu M, Chen H, Zhang M, Wang R, Yuan Y, Li X. Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial. JAMA. 2024 Aug 20;332(7):551-560. doi: 10.1001/jama.2024.9217.
PubMed 38819983
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tirzepatide Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-CN)
- ClinicalTrials.gov ID
- NCT05024032
- Acronym / sponsor ID
- SURMOUNT-CN / 17507
- Conditions
- Obesity, Overweight, Metabolism and Nutrition Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Posted 19 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight.
The main purpose is to learn more about how tirzepatide affects body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 Milligrams (mg) Tirzepatide | Experimental | Drug: TirzepatideParticipants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW). |
| 15 mg Tirzepatide | Experimental | Drug: TirzepatideParticipants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo SC QW. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
Key exclusion criteria (7 listed)
- Have Diabetes Mellitus
- Have a self-reported change in body weight >5 kg within 3 months prior to screening
- Have obesity induced by other endocrinological disorders
- Have had a history of chronic or acute pancreatitis
- Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | 10 Milligrams (mg) Tirzepatide, 15 mg Tirzepatide |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Mean Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 52
Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time frame: Week 52
Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.
19 secondary outcomes
Mean Change From Baseline in Body Weight
Time frame: Baseline, Week 20
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame: Week 52
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time frame: Week 52
Mean Change From Baseline in Waist Circumference
Time frame: Baseline, Week 52
Mean Change From Baseline in Absolute Body Weight
Time frame: Baseline, Week 52
Mean Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 52
Mean Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 52
Mean Change From Baseline in Fasting Glucose (FSG)
Time frame: Baseline, Week 52
Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time frame: Baseline, Week 52
Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time frame: Baseline, Week 52
Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38819983Zhao L, Cheng Z, Lu Y, Liu M, Chen H, Zhang M, Wang R, Yuan Y, Li X. Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial. JAMA. 2024 Aug 20;332(7):551-560. doi: 10.1001/jama.2024.9217.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change From Baseline in Body Weight (time frame: Baseline, Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.