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Obesity With DiabetesPhase 3KaiNETIC-2NCT07284901

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

A Phase 3 study testing Ribupatide in people with Obesity With Diabetes and Overweight With Diabetes, run by Kailera at 173 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on: Percent change in body weight Change in hemoglobin A1c (HbA1c) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ribupatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,270 participants
Where
173 sitesin 11 countries
Study dates
12 Jan 2026to 24 Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Diagnosis of type 2 diabetes mellitus (T2DM).
  • Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
  • BMI ≥27 kg/m^2.
  • History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.

Who cannot join

  • Current diagnosis or history of type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
  • History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
  • History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
  • Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, or phentermine.
  • Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
  • Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
Show all 13Show fewer
  • Uncontrolled hypertension or unstable cardiovascular disease.
  • History of chronic or acute pancreatitis.
  • Known clinically significant gastric emptying abnormality or chronic treatment with medications that directly affect gastrointestinal (GI) motility if taken for >30 days continually within 3 months prior to Screening.
  • History of suicide attempt.
  • History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.
  • Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening.
  • Note: Additional inclusion/exclusion criteria may apply, per protocol.

Trial locations and contacts

173 sites in 11 countries.

173 sites in 11 countries

United States62 sites
  • Kailera Clinical Site

    Albany, New York, 12203

  • Kailera Clinical Site

    Amarillo, Texas, 79124

  • Kailera Clinical Site

    Annapolis, Maryland, 21401

  • Kailera Clinical Site

    Boston, Massachusetts, 02115

  • Kailera Clinical Site

    Bradenton, Florida, 34209

  • Kailera Clinical Site

    Brownsville, Texas, 78526

  • Kailera Clinical Site

    Chattanooga, Tennessee, 37405

  • Kailera Clinical Site

    Chickasha, Oklahoma, 73018

  • Kailera Clinical Site

    Cleveland, Ohio, 44122

  • Kailera Clinical Site

    Columbia, Maryland, 21045

  • Kailera Clinical Site

    Cullman, Alabama, 35055

  • Kailera Clinical Site

    Decatur, Georgia, 30030

  • Kailera Clinical Site

    DeSoto, Texas, 75115

  • Kailera Clinical Site

    East Greenwich, Rhode Island, 02818

  • Kailera Clinical Site

    El Paso, Texas, 79902

  • Kailera Clinical Site

    Escondido, California, 92025

  • Kailera Clinical Site

    Farmers Branch, Texas, 75234

  • Kailera Clinical Site

    Farmington Hills, Michigan, 48334

  • Kailera Clinical Site

    Greensboro, North Carolina, 27405

  • Kailera Clinical Site

    Hollywood, Florida, 33024

  • Kailera Clinical Site

    Jupiter, Florida, 33458

  • Kailera Clinical Site

    Kingwood, Texas, 77345

  • Kailera Clinical Site

    La Mesa, California, 91942

  • Kailera Clinical Site

    Las Vegas, Nevada, 89148

  • Kailera Clinical Site

    Laurelton, New York, 11413

  • Kailera Clinical Site

    Lilburn, Georgia, 30047

  • Kailera Clinical Site

    Lincoln, Nebraska, 68516

  • Kailera Clinical Site

    Little Rock, Arkansas, 72205

  • Kailera Clinical Site

    Manassas, Virginia, 20110

  • Kailera Clinical Site

    Marietta, Georgia, 30060

  • Kailera Clinical Site

    Memphis, Tennessee, 38119

  • Kailera Clinical Site

    Miami, Florida, 33135

  • Kailera Clinical Site

    Miami Lakes, Florida, 33016

  • Kailera Clinical Site

    Missoula, Montana, 59804

  • Kailera Clinical Site

    Monroe, North Carolina, 28112

  • Kailera Clinical Site

    Montclair, California, 91763

  • Kailera Clinical Site #1

    Morehead City, North Carolina, 28557

  • Kailera Clinical Site #2

    Morehead City, North Carolina, 28557

  • Kailera Clinical Site

    Morrisville, North Carolina, 27560

  • Kailera Clinical Site

    New York, New York, 10016

  • Kailera Clinical Site

    Newton, Kansas, 67114

  • Kailera Clinical Site

    Northridge, California, 91325

  • Kailera Clinical Site

    Oceanside, California, 92058

  • Kailera Clinical Site

    Orange City, Florida, 32763

  • Kailera Clinical Site

    Orlando, Florida, 32801

  • Kailera Clinical Site

    Orlando, Florida, 32803

  • Kailera Clinical Site

    Phoenix, Arizona, 85012

  • Kailera Clinical Site

    Plano, Texas, 75093

  • Kailera Clinical Site

    Pleasant View, Utah, 84404

  • Kailera Clinical Site

    Richmond, Virginia, 23236

  • Kailera Clinical Site

    Riverdale, Georgia, 30274

  • Kailera Clinical Site

    Salt Lake City, Utah, 84117

  • Kailera Clinical Site

    Seattle, Washington, 98104

  • Kailera Clinical Site

    Shreveport, Louisiana, 71105

  • Kailera Clinical Site

    Skokie, Illinois, 60077

  • Kailera Clinical Site

    Spartanburg, South Carolina, 29303

  • Kailera Clinical Site

    Springfield, Illinois, 62702

  • Kailera Clinical Site

    Stamford, Connecticut, 06905

  • Kailera Clinical Site

    Sun City, Arizona, 85351

  • Kailera Clinical Site

    The Villages, Florida, 32162

  • Kailera Clinical Site

    Toluca Lake, California, 91602

  • Kailera Clinical Site

    Tomball, Texas, 77375

Other trials in United States

Argentina17 sites
  • Kailera Clinical Site #1

    Buenos Aires, 1056

  • Kailera Clinical Site #2

    Buenos Aires, 1056

  • Kailera Clinical Site

    Buenos Aires, 1060

  • Kailera Clinical Site

    Buenos Aires, 1061

  • Kailera Clinical Site

    Buenos Aires, 1128

  • Kailera Clinical Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1120

  • Kailera Clinical Site

    Córdoba, 5000

  • Kailera Clinical Site

    Córdoba, 5002

  • Kailera Clinical Site

    Godoy Cruz, Mendoza Province, 5501

  • Kailera Clinical Site

    La Plata, Buenos Aires, 1900

  • Kailera Clinical Site

    Mar del Plata, Buenos Aires, 7600

  • Kailera Clinical Site #1

    Rosario, Santa Fe Province, 2000

  • Kailera Clinical Site #2

    Rosario, Santa Fe Province, 2000

  • Kailera Clinical Site #3

    Rosario, Santa Fe Province, 2000

  • Kailera Clinical Site #4

    Rosario, Sante Fe, 2000

  • Kailera Clinical Site

    San Nicolás de los Arroyos, Buenos Aires, 2900

  • Kailera Clinical Site

    Zárate, Buenos Aires, 2800

Other trials in Argentina

Australia14 sites
  • Kailera Clinical Site

    Blacktown, New South Wales, 2148

  • Kailera Clinical Site

    Bruce, Australian Capital Territory, 2617

  • Kailera Clinical Site

    Camberwell, Victoria, 3124

  • Kailera Clinical Site

    Charlestown, New South Wales, 2290

  • Kailera Clinical Site

    Herston, Queensland, 4006

  • Kailera Clinical Site

    Kanwal, New South Wales, 2259

  • Kailera Clinical Site

    Leichhardt, New South Wales, 2040

  • Kailera Clinical Site

    Melbourne, Victoria, 3025

  • Kailera Clinical Site

    Morayfield, Queensland, 4506

  • Kailera Clinical Site

    Penrith, New South Wales, 2750

  • Kailera Clinical Site

    South Brisbane, 4101

  • Kailera Clinical Site

    Sydney, New South Wales, 2100

  • Kailera Clinical Site

    Sydney, New South Wales, 2228

  • Kailera Clinical Site

    Wollongong, New South Wales, 2500

Other trials in Australia

Poland14 sites
  • Kailera Clinical Site

    Bialystok, Podlaskie Voivodeship, 15-351

  • Kailera Clinical Site

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231

  • Kailera Clinical Site

    Chorzów, Silesian Voivodeship, 41-500

  • Kailera Clinical Site #1

    Gdynia, Pomeranian Voivodeship, 81-338

  • Kailera Clinical Site #2

    Gdynia, Pomeranian Voivodeship, 81-338

  • Kailera Clinical Site

    Kielce, Świętokrzyskie Voivodeship, 25-338

  • Kailera Clinical Site

    Krakow, Lesser Poland Voivodeship, 30-033

  • Kailera Clinical Site

    Krakow, 30-363

  • Kailera Clinical Site

    Lublin, Lublin Voivodeship, 20-718

  • Kailera Clinical Site

    Siedlce, Masovian Voivodeship, 08-110

  • Kailera Clinical Site

    Skierniewice, Łódź Voivodeship, 96-100

  • Kailera Clinical Site

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Kailera Clinical Site

    Warsaw, Masovian Voivodeship, 00-872

  • Kailera Clinical Site

    Warsaw, 02-677

Other trials in Poland

United Kingdom13 sites
  • Kailera Clinical Site

    Bournemouth, Dorset, BH7 7DW

  • Kailera Clinical Site

    Bradford, West Yorkshire, BD9 6RJ

  • Kailera Clinical Site

    Glasgow, Glasgow City, G51 4TF

  • Kailera Clinical Site

    Hull, East Yorkshire, HU3 2JZ

  • Kailera Clinical Site

    Leicester, Leicestershire, LE5 4PW

  • Kailera Clinical Site

    London, Greater London, EC1M 6BQ

  • Kailera Clinical Site

    Manchester, M13 9WL

  • Kailera Clinical Site

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

  • Kailera Clinical Site

    Nottingham, Nottinghamshire, NG7 2QW

  • Kailera Clinical Site

    Plymouth, Devon, PL6 8DH

  • Kailera Clinical Site

    Stevenage, Hertfordshire, SG1 4AB

  • Kailera Clinical Site

    Truro, Cornwall, TR1 3LJ

  • Kailera Clinical Site

    Yate, South Gloucestershire, BS37 4AX

Other trials in United Kingdom

Czechia12 sites
  • Kailera Clinical Site

    Bohnice, Prague, 18100

  • Kailera Clinical Site

    Brandýs nad Labem, Central Bohemia, 25001

  • Kailera Clinical Site

    Brno, South Moravian, 60200

  • Kailera Clinical Site

    Hodonín, 69501

  • Kailera Clinical Site

    Holešov, Zlín, 76901

  • Kailera Clinical Site

    Náchod, Hradec Králové Region, 54701

  • Kailera Clinical Site

    Olomouc, 77900

  • Kailera Clinical Site

    Pardubice, 53002

  • Kailera Clinical Site

    Prague, Prague, 14059

  • Kailera Clinical Site

    Prague, 15000

  • Kailera Clinical Site

    Trutnov, Hradec Králové Region, 54101

  • Kailera Clinical Site

    Uherské Hradiště, 68601

Other trials in Czechia

Bulgaria10 sites
  • Kailera Clinical Site

    Kyustendil, Kyustendil Province, 2500

  • Kailera Clinical Site

    Montana, 3400

  • Kailera Clinical Site

    Pleven, Pleven Province, 5800

  • Kailera Clinical Site

    Plovdiv, Plovdiv Province, 4020

  • Kailera Clinical Site

    Rousse, Ruse Province, 7013

  • Kailera Clinical Site

    Sofia, Sofia, 1527

  • Kailera Clinical Site

    Sofia, Sofia, 1606

  • Kailera Clinical Site

    Sofia, Sofia, 1618

  • Kailera Clinical Site

    Stara Zagora, Stara Zagora Province, 6000

  • Kailera Clinical Site

    Varna, Varna Province, 9000

Other trials in Bulgaria

Spain10 sites
  • Kailera Clinical Site

    Barcelona, Catalonia, 08035

  • Kailera Clinical Site

    Castilleja de la Cuesta, Sevilla, 41950

  • Kailera Clinical Site

    Ferrol, A Coruna, 15402

  • Kailera Clinical Site

    Madrid, 28003

  • Kailera Clinical Site

    Oviedo, Principality of Asturias, 33011

  • Kailera Clinical Site

    Seville, Andalusia, 41010

  • Kailera Clinical Site

    Seville, 41003

  • Kailera Clinical Site

    Seville, 41013

  • Kailera Clinical Site

    Valencia, 46014

  • Kailera Clinical Site

    Villamartín, Cadiz, 11650

Other trials in Spain

New Zealand8 sites
  • Kailera Clinical Site

    Auckland, 1023

  • Kailera Clinical Site

    Grafton, Auckland, 1010

  • Kailera Clinical Site

    Hastings, 4120

  • Kailera Clinical Site

    Nawton, Hamilton, 3200

  • Kailera Clinical Site

    Nelson, 7011

  • Kailera Clinical Site

    New Lynn, Auckland, 0610

  • Kailera Clinical Site

    Silverdale, Auckland, 0932

  • Kailera Clinical Site

    Takapuna, Auckland, 0622

Other trials in New Zealand

Germany7 sites
  • Kailera Clinical Site

    Cologne, North Rhine-Westphalia, 51069

  • Kailera Clinical Site #1

    Essen, North Rhine-Westphalia, 45355

  • Kailera Clinical Site #2

    Essen, North Rhine-Westphalia, 45355

  • Kailera Clinical Site

    Falkensee, Brandenburg, 14612

  • Kailera Clinical Site

    Oldenburg in Holstein, Schleswig-Holstein, 23758

  • Kailera Clinical Site

    Schwerin, 19055

  • Kailera Clinical Site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Puerto Rico6 sites
  • Kailera Clinical Site #1

    Bayamón, 00959

  • Kailera Clinical Site #2

    Bayamón, 00959

  • Kailera Clinical Site

    Ponce, 00716

  • Kailera Clinical Site

    San Juan, 00907

  • Kailera Clinical Site

    San Juan, 00909

  • Kailera Clinical Site

    Vega Baja, 693

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on:

  • Percent change in body weight
  • Change in hemoglobin A1c (HbA1c)
Being tested
Ribupatide, Placebo
Keywords
Obesity, Overweight, Ribupatide, KAI-9531, Glucagon-like peptide-1, GLP-1, Diabetes, Glucose-dependent Insulinotropic Peptide, GIP
Medical subject headings
Obesity, Overweight, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibupatideDrug

    Also called KAI-9531

    SC Injection

  • PlaceboDrug

    SC Injection

Study groups in NCT07284901
Study groupRoleWhat they receive
Ribupatide: Dose 1ExperimentalParticipants will receive Dose 1 of ribupatide once weekly.
Receives: Drug: Ribupatide
Ribupatide: Dose 2ExperimentalParticipants will receive Dose 2 of ribupatide once weekly.
Receives: Drug: Ribupatide
Ribupatide: Dose 3ExperimentalParticipants will receive Dose 3 of ribupatide once weekly.
Receives: Drug: Ribupatide
Ribupatide: Dose 4ExperimentalParticipants will receive Dose 4 of ribupatide once weekly.
Receives: Drug: Ribupatide
PlaceboPlacebo comparatorParticipants will receive placebo matched to ribupatide once weekly.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Measured: Baseline, Week 76

  2. Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

    Measured: Baseline, Week 76

Secondary outcomes (33)
  1. Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Measured: Baseline, Week 76

  2. Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

    Measured: Baseline, Week 76

  3. Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

    Measured: Baseline, Week 76

  4. Change From Baseline in Waist Circumference

    Measured: Baseline, Week 76

  5. Change From Baseline in Absolute Body Weight

    Measured: Baseline, Week 76

  6. Percentage of Participants with HbA1c <7% and ≤6.5%

    Measured: Baseline, Week 76

  7. Change From Baseline in Fasting Blood Glucose

    Measured: Baseline, Week 76

  8. Change From Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 76

  9. Percent Change From Baseline in Fasting Triglycerides

    Measured: Baseline, Week 76

  10. Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol

    Measured: Baseline, Week 76

  11. Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Measured: Baseline, Week 76

  12. Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

    Measured: Baseline, Week 76

  13. Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight

    Measured: Baseline, Week 76

  14. Percentage of Participants with ≥30% Reduction in Body Weight

    Measured: Baseline, Week 76

  15. Change From Baseline in BMI

    Measured: Baseline, Week 76

  16. Percentage of Participants with HbA1c <5.7%

    Measured: Baseline, Week 76

  17. Change From Baseline in Diastolic Blood Pressure (DBP)

    Measured: Baseline, Week 76

  18. Percent Change From Baseline in Fasting Total Cholesterol

    Measured: Baseline, Week 76

  19. Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol

    Measured: Baseline, Week 76

  20. Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol

    Measured: Baseline, Week 76

  21. Percent Change From Baseline in Fasting Insulin

    Measured: Baseline, Week 76

  22. Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score

    Measured: Baseline, Week 76

  23. Change From Baseline in CoEQ Positive Mood Score

    Measured: Baseline, Week 76

  24. Change From Baseline in CoEQ Craving for Sweets Score

    Measured: Baseline, Week 76

  25. Change From Baseline in CoEQ Craving for Savory Food Score

    Measured: Baseline, Week 76

  26. Change From Baseline in CoEQ Hunger Score

    Measured: Baseline, Week 76

  27. Change From Baseline in CoEQ Satiety Score

    Measured: Baseline, Week 76

  28. Change From Baseline in CoEQ Combined Score

    Measured: Baseline, Week 76

  29. Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Measured: Baseline, Week 76

  30. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: Day 1 up to Week 80

  31. Number of Participants With Anti-drug Antibodies (ADAs)

    Measured: Up to Week 80

  32. Number of Participants With Neutralizing Antibodies (Nabs)

    Measured: Up to Week 80

  33. Plasma Concentrations of Ribupatide

    Measured: Up to Week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start12 Jan 2026
  3. Primary completion27 Mar 2028 (estimated)
  4. Study completion24 Apr 2028 (estimated)

Resources

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
1,270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07284901
Sponsor's protocol ID
K9531-3104
Other IDs
2025-523510-87-00, 2025
Acronym
KaiNETIC-2
Status last verified
Oct 2026
First submitted
9 Dec 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ribupatide in people with Obesity With Diabetes and Overweight With Diabetes, run by Kailera at 173 sites in 11 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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United States, Argentina, Australia, Poland, United Kingdom and 6 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 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?

This study is still under way. Results are not available in the source record yet.

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?

Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 (time frame: Baseline, Week 76). 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?
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 6 Oct 2026.

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