NCT07284901ClinicalTrials.gov

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

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

RecruitingTaking participants now, according to the registry record.

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In brief

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)

Phase 31,156 participants sought167 sites11 countries

Registered in 1 registry

ClinicalTrials.govNCT07284901Open this record at ClinicalTrials.govSynced 2 weeks ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-12-16; recorded start 2026-01-12
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 7 other studies in this databaseCounted from the lead sponsor named in the record (Kailera)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding13/20
Double-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 116 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,156 participants (target), run at 167 sites, across 11 countries.

How this score is built

Enrolment30/40
1,156 participants (target)
Site count23/25
116 sites
Country count12/15
11 countries
Planned duration7/10
Planned over about 28 months
Sponsor scale3/10
Kailera has led 7 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Conditions

Obesity With Diabetes
Overweight With Diabetes

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. * 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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	DOUBLE (2)
Enrolment	1,156 participants sought

Sponsor and collaborators

Kailera Sponsor

Arms and interventions

Ribupatide: Dose 1EXPERIMENTAL
Participants will receive Dose 1 of ribupatide once weekly.
Ribupatide: Dose 2EXPERIMENTAL
Participants will receive Dose 2 of ribupatide once weekly.
Ribupatide: Dose 3EXPERIMENTAL
Participants will receive Dose 3 of ribupatide once weekly.
Ribupatide: Dose 4EXPERIMENTAL
Participants will receive Dose 4 of ribupatide once weekly.
PlaceboPLACEBO_COMPARATOR
Participants will receive placebo matched to ribupatide once weekly.

Interventions

Drug Placebo
SC Injection
Drug Ribupatide
SC Injection

Outcome measures

Primary outcome
Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame Baseline, Week 76
Primary outcome
Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Time frame Baseline, Week 76
Secondary outcome
Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame Baseline, Week 76
Secondary outcome
Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Time frame Baseline, Week 76
Secondary outcome
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in Waist Circumference
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in Absolute Body Weight
Time frame Baseline, Week 76
Secondary outcome
Percentage of Participants with HbA1c <7% and ≤6.5%
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in Fasting Blood Glucose
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame Baseline, Week 76
Secondary outcome
Percent Change From Baseline in Fasting Triglycerides
Time frame Baseline, Week 76
Secondary outcome
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time frame Baseline, Week 76
Secondary outcome
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time frame Baseline, Week 76
Secondary outcome
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 76
Secondary outcome
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
Time frame Baseline, Week 76
Secondary outcome
Percentage of Participants with ≥30% Reduction in Body Weight
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in BMI
Time frame Baseline, Week 76
Secondary outcome
Percentage of Participants with HbA1c <5.7%
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame Baseline, Week 76
Secondary outcome
Percent Change From Baseline in Fasting Total Cholesterol
Time frame Baseline, Week 76
Secondary outcome
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Time frame Baseline, Week 76
Secondary outcome
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Time frame Baseline, Week 76
Secondary outcome
Percent Change From Baseline in Fasting Insulin
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in CoEQ Positive Mood Score
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in CoEQ Craving for Sweets Score
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in CoEQ Craving for Savory Food Score
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in CoEQ Hunger Score
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in CoEQ Satiety Score
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in CoEQ Combined Score
Time frame Baseline, Week 76
Secondary outcome
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Time frame Baseline, Week 76
Secondary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame Day 1 up to Week 80
Secondary outcome
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame Up to Week 80
Secondary outcome
Number of Participants With Neutralizing Antibodies (Nabs)
Time frame Up to Week 80
Secondary outcome
Plasma Concentrations of Ribupatide
Time frame Up to Week 76

Dates

Dates
Start date	January 12, 2026 (actual)
Primary completion	March 27, 2028 (estimated)
Completion	April 24, 2028 (estimated)
First posted	December 16, 2025 (actual)
Last updated	September 3, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

165 sites are recruiting

Argentina

Argentina
Facility	City	State or region	Status
Kailera Clinical Site	Buenos Aires		Recruiting
Kailera Clinical Site	Buenos Aires		Recruiting
Kailera Clinical Site	Buenos Aires		Recruiting
Kailera Clinical Site	Buenos Aires		Recruiting
Kailera Clinical Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Recruiting
Kailera Clinical Site	Córdoba		Recruiting
Kailera Clinical Site	Córdoba		Recruiting
Kailera Clinical Site	Godoy Cruz	Mendoza Province	Recruiting
Kailera Clinical Site	La Plata	Buenos Aires	Recruiting
Kailera Clinical Site	Mar del Plata	Buenos Aires	Recruiting
Kailera Clinical Site	Rosario	Santa Fe Province	Recruiting
Kailera Clinical Site	Rosario	Sante Fe	Recruiting
Kailera Clinical Site	San Nicolás de los Arroyos	Buenos Aires	Recruiting
Kailera Clinical Site	Zárate	Buenos Aires	Recruiting

Australia

Australia
Facility	City	State or region	Status
Kailera Clinical Site	Blacktown	New South Wales	Recruiting
Kailera Clinical Site	Bruce	Australian Capital Territory	Recruiting
Kailera Clinical Site	Camberwell	Victoria	Recruiting
Kailera Clinical Site	Charlestown	New South Wales	Recruiting
Kailera Clinical Site	Herston	Queensland	Recruiting
Kailera Clinical Site	Kanwal	New South Wales	Recruiting
Kailera Clinical Site	Leichhardt	New South Wales	Recruiting
Kailera Clinical Site	Melbourne	Victoria	Recruiting
Kailera Clinical Site	Morayfield	Queensland	Recruiting
Kailera Clinical Site	Penrith	New South Wales	Recruiting
Kailera Clinical Site	South Brisbane		Recruiting
Kailera Clinical Site	Sydney	New South Wales	Recruiting
Kailera Clinical Site	Sydney	New South Wales	Recruiting
Kailera Clinical Site	Wollongong	New South Wales	Recruiting

Bulgaria

Bulgaria
Facility	City	State or region	Status
Kailera Clinical Site	Kyustendil	Kyustendil Province	Recruiting
Kailera Clinical Site	Montana		Recruiting
Kailera Clinical Site	Pleven	Pleven Province	Recruiting
Kailera Clinical Site	Plovdiv	Plovdiv Province	Recruiting
Kailera Clinical Site	Rousse	Ruse Province	Recruiting
Kailera Clinical Site	Sofia	Sofia	Recruiting
Kailera Clinical Site	Sofia	Sofia	Recruiting
Kailera Clinical Site	Sofia	Sofia	Recruiting
Kailera Clinical Site	Stara Zagora	Stara Zagora Province	Recruiting
Kailera Clinical Site	Varna	Varna Province	Recruiting

Czechia

Czechia
Facility	City	State or region	Status
Kailera Clinical Site	Bohnice	Prague	Recruiting
Kailera Clinical Site	Brandýs nad Labem	Central Bohemia	Recruiting
Kailera Clinical Site	Brno	South Moravian	Recruiting
Kailera Clinical Site	Hodonín		Recruiting
Kailera Clinical Site	Holešov	Zlín	Recruiting
Kailera Clinical Site	Náchod	Hradec Králové Region	Recruiting
Kailera Clinical Site	Olomouc		Recruiting
Kailera Clinical Site	Pardubice		Recruiting
Kailera Clinical Site	Prague		Recruiting
Kailera Clinical Site	Prague	Prague	Recruiting
Kailera Clinical Site	Trutnov	Hradec Králové Region	Recruiting
Kailera Clinical Site	Uherské Hradiště		Recruiting

117 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 3, 2026
Site added
4 sites added (167 total)
163167
September 1, 2026
Site added
47 sites added (163 total)
116163

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07284901

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Bulgaria

Czechia

Study documents

Changes over time