Genetic ObesityPhase 2NCT04963231
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
A Phase 2 study testing Setmelanotide in people with Genetic Obesity, run by Rhythm Pharmaceuticals, Inc. at 36 sites in 8 countries.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of once daily subcutaneous (SC) administration of setmelanotide in participants with obesity and specific gene variants in the MC4R pathway. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Genetic Obesity
- What is being tested?
- Setmelanotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 36 sitesin 8 countries
- Study dates
- 30 Nov 2021to 30 Sep 2024
- Phase
- Phase 2
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must have had a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity
- Age 6 to 65 years, inclusive
- Obesity, defined as Body Mass Index (BMI) ≥40 kilograms per square meter (kg/m^2) for participants ≥18 years of age or BMI ≥97th percentile for age and gender for participants 6 to <18 years of age
- Study participant and/or parent or guardian were able to understand all study procedures and provide consent/assent
- Use of highly effective contraception
- Symptoms or behaviors of hyperphagia
Who cannot join
- Participants with the following genetic variants: biallelic Bardet-Biedl Syndrome (BBS); biallelic Alström Syndrome 1 (ALMS1); homozygous, heterozygous, or compound heterozygous variants in MC4R, Pro-opiomelanocortin (POMC), Proprotein convertase subtilisin/kexin type 1 (PCSK1), Leptin receptor (LEPR), nuclear receptor coactivator 1 (NCOA1; steroid receptor coactivator-1 [SRC1]) or SRC homology 2 B adapter protein 1 (SH2B1) genes as well as 16p11.2 chromosomal deletions that included the SH2B1 gene
- Recent intensive diet and/or exercise regimen with or without the use of weight loss agents including herbal medications that had resulted in weight loss >2% within previous 3 months
- Bariatric surgery within the previous 6 months
- Documented diagnosis of current unstable major psychiatric disorder or a documented worsening of psychiatric condition that required changes in treatment within 2 years
- Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) or Patient Health Questionnaire 9 (PHQ 9) score of ≥15 during Screening, any suicide attempt in participant's lifetime years, or any suicidal behavior in the last month.
- Current, clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study
Show all 17Show fewer
- Has significant features of (or meets the diagnostic criteria for) a genetic syndrome that is associated with obesity
- Glycated hemoglobin (HbA1C) >10.0% at Screening
- History of significant liver disease
- Glomerular filtration rate (GFR) <30 milliliter per minute (mL/min) at Screening
- History or close family history of melanoma or participant history of oculocutaneous albinism
- Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions
- Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing
- Participants previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide
- Significant hypersensitivity to any excipient in the study drug
- Females who were breastfeeding or nursing
- Other protocol defined Inclusion/Exclusion criteria applied.
Trial locations and contacts
36 sites in 8 countries.
36 sites in 8 countries
United States21 sites
Texas Tech
Amarillo, Texas, 79106
University of Michigan
Ann Arbor, Michigan, 48105
University of North Carolina
Chapel Hill, North Carolina, 27517
Endocrine Associates of Dallas and Plano
Dallas, Texas, 75231
Geisinger Clinic
Danville, Pennsylvania, 17822
Metro Detroit Endocrinology Center
Dearborn, Michigan, 48126
Hector Granados PA
El Paso, Texas, 79907
Texas Children's Hospital
Houston, Texas, 77030
Accurate Clinical Research
Houston, Texas, 77065
Mississippi Center for Advanced Medicine
Madison, Mississippi, 39110
Rio Grande Valley Endocrine Center
McAllen, Texas, 78503
Mount Sinai
New York, New York, 10029
Columbia University
New York, New York, 10032
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Trials of Texas
San Antonio, Texas, 78229
HonorHealth Bariatric Center
Scottsdale, Arizona, 85258
Ten's Medical Center - Pediatric Endocrinology Clinic
Staten Island, New York, 10308
InQuest Medical Reseacrh
Suwanee, Georgia, 30071
Javara Research
The Woodlands, Texas, 77382
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Spain4 sites
Hospital Sant Joan de Deu
Barcelona, 08950
Hospital Infantil Universitario Nino Jesus
Madrid, 28009
Hospital Fundación Jimenez Díaz
Madrid, 28040
Hospital General de Valencia
Valencia, 46014
United Kingdom4 sites
Bristol Royal Hospital for Children
Bristol
University of Cambridge
Cambridge
London Medical - The London Diabetes Centre
London, NW1 2PG
University College London Hospitals NHS Foundation Trust
London, WC1E 6JF
Germany3 sites
Charite - Universitatsmedizin Berlin
Berlin
Universitaetsklinikum Leipzig
Leipzig, 04103
Universitaetsklinikum Ulm
Ulm, 89075
About this study
Official title: A 2-Stage (Open-Label Followed by Randomized Double-Blind, Placebo-Controlled Stage), Phase 2 Trial of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway
The purpose of this study was to evaluate the safety and efficacy of once daily subcutaneous (SC) administration of setmelanotide in participants with obesity and specific gene variants in the MC4R pathway.
- Conditions
- Genetic Obesity
- Being tested
- Setmelanotide, Placebo
- Keywords
- Melanocortin-4 Receptor, Genetic Obesity, Leptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetmelanotideDrug
SC injection
PlaceboDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Setmelanotide (Open-Label) | Experimental | Participants received once daily SC injection of setmelanotide from Day 1 to Week 16 in an open-label treatment stage (Stage 1). Participants ≥12 years of age started on setmelanotide 2.0 milligrams (mg) once daily for approximately 2 weeks, then increased to 3.0 mg once daily. Participants <12 years of age started on setmelanotide 1.0 mg once daily for approximately 1 week, then increased to 2.0 mg once daily for approximately 1 week, then increased to 3.0 mg once daily. Receives: Drug: Setmelanotide |
| Stage 2: Setmelanotide (Double-Blind) | Experimental | Participants from Stage 1 who were eligible for Stage 2 received once daily SC injection of setmelanotide 3.0 mg from Week 16 to Week 40 in a double-blind treatment Stage (Stage 2). Receives: Drug: Setmelanotide |
| Stage 2: Placebo (Double-Blind) | Placebo comparator | Participants from Stage 1 who were eligible for Stage 2 received once daily SC injection of matching placebo 3.0 mg from Week 16 to Week 40 in a double-blind treatment Stage (Stage 2). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Number of Participants by Genotype Who Demonstrated a Significant Clinically Meaningful Response to Setmelanotide at the End of Stage 1
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = Kilogram (kg)/ square meter (m^2).
A significant clinically meaningful response was defined as achieving a ≥5% reduction in BMI from Baseline.
Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Measured: Baseline to Week 16
Secondary outcomes (9)
Mean Change in BMI From Baseline to the End of Stage 1 in All Participants, Per Genotype
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2.
Data are provided for overall and according to participants with specified primary gene.
Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Measured: Baseline, Week 16
Mean Change in BMI From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2 Data are provided for overall and according to participants with specified primary gene.
Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Measured: Baseline, Week 16
Percent Change in BMI From Baseline to the End of Stage 1 in All Participants, Per Genotype
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2 Data are provided for overall and according to participants with specified primary gene.
Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Measured: Baseline, Week 16
Percent Change in BMI From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2 Data are provided for overall and according to participants with specified primary gene.
Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Measured: Baseline, Week 16
Mean Change in Body Weight From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype
Data are provided for overall and according to participants with specified primary gene.
Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Measured: Baseline, Week 16
Percent Change in Body Weight From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype
Data are provided for overall and according to participants with specified primary gene.
Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Measured: Baseline, Week 16
Mean Change in BMI Z-score From Baseline to the End of Stage 1 in Participants <18 Years Old, Per Genotype
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2. The BMI Z-score indicated the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease of BMI Z-score indicates a reduction in BMI from Baseline whereas an increase of BMI-Z score indicates an increase in BMI from Baseline.
Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Measured: Baseline, Week 16
Percent Change in the Weekly Average of the Daily Maximal Hunger Score From Baseline to the End of Stage 1 in Participants ≥12 Years Old, Per Genotype
Daily Hunger Questionnaire for participants ≥12 years of age is self-administered questionnaire and comprises three items. For the assessment of this endpoint, maximal hunger was corresponding to the following question: In the last 24 hours, how hungry did you feel when you were the most hungry? The response was scored separately and averaged on weekly basis. Participants rated their hunger on an 11-point numeric rating scale ranging from 0 to 10 (0 = not hungry at all, and 10 = hungriest possible).
Weekly average at Week 16 was defined as average of the available score values within 7 days in Week 16.
Baseline was defined as the average of the available score values within 7 days before or on the stage 1 open-label treatment.
Results are reported by overall participant results and by specific gene cohort.
Measured: Baseline, Week 16
Number of Participants ≥12 Years Old, Who Achieved a ≥2 Point Reduction From Baseline to the End of Stage 1 in the Weekly Average of the Daily Maximal Hunger Score, Per Genotype
Daily Hunger Questionnaire for participants ≥12 years of age is self-administered questionnaire and comprises three items. For the assessment of this endpoint, maximal hunger was corresponding to the following question: In the last 24 hours, how hungry did you feel when you were the most hungry? The response was scored separately and averaged on weekly basis. Participants rated their hunger on an 11-point numeric rating scale ranging from 0 to 10 (0 = not hungry at all, and 10 = hungriest possible).
Weekly average at Week 16 was defined as average of the available score values within 7 days in Week 16.
Baseline was defined as the average of the available score values within 7 days before or on the stage 1 open-label treatment.
Results are reported by overall participant results and by specific gene cohort.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start30 Nov 2021
- Primary completion4 Aug 2023
- Study completion30 Sep 2024
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 (2)Papers the sponsor has linked to this study.
- Other trials for Genetic ObesityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Meeker, MD, Study chair, Rhythm Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963231
- Sponsor's protocol ID
- RM-493-034
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2021
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trapp CM, Censani M. Setmelanotide: a promising advancement for pediatric patients with rare forms of genetic obesity. Curr Opin Endocrinol Diabetes Obes. 2023 Apr 1;30(2):136-140. doi: 10.1097/MED.0000000000000798. Epub 2023 Feb 1.
PubMed 36722447Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5.
PubMed 35797460
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Stage (Open-Label Followed by Randomized Double-Blind, Placebo-Controlled Stage), Phase 2 Trial of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway
- ClinicalTrials.gov ID
- NCT04963231
- Acronym / sponsor ID
- RM-493-034
- Conditions
- Genetic Obesity
- Keywords
- Melanocortin-4 Receptor, Genetic Obesity, Leptin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety and efficacy of once daily subcutaneous (SC) administration of setmelanotide in participants with obesity and specific gene variants in the MC4R pathway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Setmelanotide (Open-Label) | Experimental | Drug: SetmelanotideParticipants received once daily SC injection of setmelanotide from Day 1 to Week 16 in an open-label treatment stage (Stage 1). Participants ≥12 years of age started on setmelanotide 2.0 milligrams (mg) once daily for approximately 2 weeks, then increased to 3.0 mg once daily. Participants <12 years of age started on setmelanotide 1.0 mg once daily for approximately 1 week, then increased to 2.0 mg once daily for approximately 1 week, then increased to 3.0 mg once daily. |
| Stage 2: Setmelanotide (Double-Blind) | Experimental | Drug: SetmelanotideParticipants from Stage 1 who were eligible for Stage 2 received once daily SC injection of setmelanotide 3.0 mg from Week 16 to Week 40 in a double-blind treatment Stage (Stage 2). |
| Stage 2: Placebo (Double-Blind) | Placebo comparator | Drug: PlaceboParticipants from Stage 1 who were eligible for Stage 2 received once daily SC injection of matching placebo 3.0 mg from Week 16 to Week 40 in a double-blind treatment Stage (Stage 2). |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have had a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity
- Age 6 to 65 years, inclusive
- Obesity, defined as Body Mass Index (BMI) ≥40 kilograms per square meter (kg/m^2) for participants ≥18 years of age or BMI ≥97th percentile for age and gender for participants 6 to <18 years of age
- Study participant and/or parent or guardian were able to understand all study procedures and provide consent/assent
- Use of highly effective contraception
Key exclusion criteria (17 listed)
- Participants with the following genetic variants: biallelic Bardet-Biedl Syndrome (BBS); biallelic Alström Syndrome 1 (ALMS1); homozygous, heterozygous, or compound heterozygous variants in MC4R, Pro-opiomelanocortin (POMC), Proprotein convertase subtilisin/kexin type 1 (PCSK1), Leptin receptor (LEPR), nuclear receptor coactivator 1 (NCOA1; steroid receptor coactivator-1 [SRC1]) or SRC homology 2 B adapter protein 1 (SH2B1) genes as well as 16p11.2 chromosomal deletions that included the SH2B1 gene
- Recent intensive diet and/or exercise regimen with or without the use of weight loss agents including herbal medications that had resulted in weight loss >2% within previous 3 months
- Bariatric surgery within the previous 6 months
- Documented diagnosis of current unstable major psychiatric disorder or a documented worsening of psychiatric condition that required changes in treatment within 2 years
- Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) or Patient Health Questionnaire 9 (PHQ 9) score of ≥15 during Screening, any suicide attempt in participant's lifetime years, or any suicidal behavior in the last month.
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 |
|---|---|---|
| SetmelanotideSC injection | Drug | Stage 1: Setmelanotide (Open-Label), Stage 2: Setmelanotide (Double-Blind) |
| PlaceboSC injection | Drug | Stage 2: Placebo (Double-Blind) |
Primary outcome
Stage 1: Number of Participants by Genotype Who Demonstrated a Significant Clinically Meaningful Response to Setmelanotide at the End of Stage 1
Time frame: Baseline to Week 16
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = Kilogram (kg)/ square meter (m^2). A significant clinically meaningful response was defined as achieving a ≥5% reduction in BMI from Baseline. Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
9 secondary outcomes
Mean Change in BMI From Baseline to the End of Stage 1 in All Participants, Per Genotype
Time frame: Baseline, Week 16
Mean Change in BMI From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype
Time frame: Baseline, Week 16
Percent Change in BMI From Baseline to the End of Stage 1 in All Participants, Per Genotype
Time frame: Baseline, Week 16
Percent Change in BMI From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype
Time frame: Baseline, Week 16
Mean Change in Body Weight From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype
Time frame: Baseline, Week 16
Percent Change in Body Weight From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype
Time frame: Baseline, Week 16
Mean Change in BMI Z-score From Baseline to the End of Stage 1 in Participants <18 Years Old, Per Genotype
Time frame: Baseline, Week 16
Percent Change in the Weekly Average of the Daily Maximal Hunger Score From Baseline to the End of Stage 1 in Participants ≥12 Years Old, Per Genotype
Time frame: Baseline, Week 16
Number of Participants ≥12 Years Old, Who Achieved a ≥2 Point Reduction From Baseline to the End of Stage 1 in the Weekly Average of the Daily Maximal Hunger Score, Per Genotype
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36722447Trapp CM, Censani M. Setmelanotide: a promising advancement for pediatric patients with rare forms of genetic obesity. Curr Opin Endocrinol Diabetes Obes. 2023 Apr 1;30(2):136-140. doi: 10.1097/MED.0000000000000798. Epub 2023 Feb 1.
- Derived from this study: PubMed 35797460Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5.
- Individual participant dataSharing planned: No
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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.
David Meeker, MD study chair
Rhythm Pharmaceuticals, Inc.
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Setmelanotide in people with Genetic Obesity, run by Rhythm Pharmaceuticals, Inc. at 36 sites in 8 countries.
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 6 inclusion and 17 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Spain, United Kingdom, Germany, Canada and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Oct 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?
Stage 1: Number of Participants by Genotype Who Demonstrated a Significant Clinically Meaningful Response to Setmelanotide at the End of Stage 1 (time frame: Baseline to Week 16). 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 NCT04963231, which also lists 2 linked publications.
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 2 Jul 2025.