Diabetes Mellitus, Type 2Phase 2NCT07172867
A Ph2 Study to Evaluate the Safety, Efficacy and Tolerability of HT-6184 and Semaglutide in Obese Participants With T2DM
A Phase 2 study testing HT-6184 and Semaglutide 1 mg in people with Diabetes Mellitus, Type 2 and Obesity, run by Halia Therapeutics, Inc. at 1 site in United Arab Emirates.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- HT-6184 and Semaglutide 1 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 6 Jan 2026to 23 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- BMI between 27 kg/m2 and 40 kg/m2.
- Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg.
- HbA1c is 7.5-10.5% at screening.
- Established diagnosis of T2DM.
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- Receiving a stable 1mg SC q1wk dose of semaglutide (Ozempic®) for ≥ 90 days prior to signing informed consent.
- Females must meet one of the following:
- Postmenopausal (>45 years of age with amenorrhea for at least 12 months, without using exogenous hormonal contraception and with FSH ≥ 40 IU/L).
- Surgically sterile (hysterectomy, bilateral salpingectomy; oophorectomy) for at least 6 months.
- Using a double contraception including a barrier method (condom, diaphragm, or occlusive cap) and a highly effective method of birth control, which includes the following:
- Established use (i.e. at least 90 days prior to signing of ICF) of combined (estrogen and progestogen) oral, intravaginal, or transdermal hormonal contraceptive associated with inhibition of ovulation ii. Established use (i.e. at least 90 days prior to signing of ICF) of progestogen-only oral, injectable, or implantable hormonal contraceptive associated with inhibition of ovulation iii. Established use (i.e. at least 90 days prior to signing of ICF) of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) iv. Bilateral tubal occlusion completed at least 90 days prior to signing of ICF d. Vasectomized partner with the appropriate post-vasectomy documentation of the absence of spermatozoa in the ejaculate. Participant must provide documentation before the first dose of ofirnoflast (study day 1).
- Sexual abstinence, when this is in line with the preferred and usual lifestyle of the participant
- Male participants who are sexually active with a woman of childbearing potential must agree to use a double contraception including a barrier method (male condom) and a highly effective method of contraception (highly effective methods of contraception are listed above) during the study and for 30 days after the last dose of ofirnoflast/ placebo.
- In the case of WOCBP, participants must have a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) at screening and negative urine pregnancy tests on first day of dosing and at each study visit.
- Able to comply with the study procedures in the view of the Investigator.
Who cannot join
- Any prescription or over-the-counter medications intended for weight loss within 6 months of screening, excluding semaglutide.
- History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (e.g. Ozempic® or Wegovy®)
- Use of other investigational drugs at the time of screening or within 30 days or 5 half-lives prior to signing of the ICF, whichever is longer, or longer if required by local regulations
- Previous or current diagnosis of Type 1 diabetes mellitus (T1DM) or current gestational diabetes.
- Diagnosis of T2DM requiring current use of insulin, repaglinide, saxagliptin, and sulfonylureas.
- Note. Use of Metformin for the purposes of glycemic control is not exclusionary.
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- History of diabetic ketoacidosis (within 90 days of screening), or proliferative or severe retinopathy (i.e., retinopathy requiring acute treatment).
- Previous bariatric surgery, liposuction, or planned weight loss surgery.
- Current or past diagnosis of pancreatitis
- Current or past diagnosis of severe gastroparesis
- Personal or within first-degree relative family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
- Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
- Laboratory abnormalities at screening
- Current or history of clinically significant (per Investigator's judgment) liver or biliary disease or significantly abnormal LFT at screening (see above)
- Current acute or chronic self-reported HCV and/or HBV infection
- Current or history of clinically significant renal disease (per Investigator's judgment) or eGFR<60mL/min/1.73m2
- Prior history of malignancy (including breast cancer, lymphoma, leukemia) within the past 5 years except for cervical carcinoma in situ that has been completely resected with no evidence of recurrence or metastatic disease for at least 12 months or cured basal cell carcinoma with no evidence of recurrence for at least 12 months.
- History of a major organ transplant (e.g. kidney, heart, liver, lung) or hematopoietic stem cell/ bone marrow transplant.
- History of lymphoproliferative disease or signs/ symptoms suggestive of possible lymphoproliferative disease, including splenomegaly of lymphadenopathy.
- History or current moderate to severe congestive heart failure (New York Heart Association class III or IV), or within the last 6 months, a cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study.
- Undergone any major surgery within 8 weeks prior to study entry or will require major surgery during the study that, in the opinion of the Investigator, would pose an unacceptable risk to the participant.
- Planning elective surgery during the study duration
- Inherited or acquired thrombophilia and/ or current or history of thromboembolic events/ disease.
- Screening 12-lead ECG that demonstrates relevant abnormalities that, in the opinion of the Investigator, are clinically significant and indicate an unacceptable risk for the participant's participation in the study (e.g., QTc >450 msec or a QRS interval >120 msec). If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the participant's eligibility.
- History or evidence of any other clinically significant concomitant disorder, condition or disease that, according to the Investigator's and medical monitor's (if consulted) judgment, would pose a risk to participant safety or interfere with the study evaluation, procedures, completion or interpretation of data
- Pregnant or breast-feeding.
- Blood donation within the last month before study day 1 (first dose of ofirnoflast or placebo)
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Cleveland Clinic Abu Dhabi
Abu Dhabi, Abu Dhabi Emirate
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study to Evaluate the Safety, Efficacy and Tolerability of Ofirnoflast (HT-6184) and Semaglutide in Obese or Overweight Participants With Type 2 Diabetes Mellitus (T2DM)
The purpose of this study is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM.
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial.
- The study duration will be up to 28 weeks.
- The screening period will be up to 4 weeks
- The treatment duration will be 12 weeks.
- The follow-up period will be 12 weeks
- The visit frequency will be every 4 weeks during the treatment phase of the study.
- There will be an anticipated 7 scheduled clinic visits, including 1 screening visit and 2 follow-up visits.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- HT-6184, HT-6184 Matching Placebo, Semaglutide 1 mg
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT-6184Drug
2mg QD
HT-6184 Matching PlaceboDrug
2mg QD
Semaglutide 1 mgDrug
Semaglutide 1 mg, every week
| Study group | Role | What they receive |
|---|---|---|
| HT-6184 2mg Treatment | Experimental | Ofirnoflast (2 mg): dosed once a day, orally (PO QD) + semaglutide (1 mg): dosed weekly (q1wk), via subcutaneous (SC) injection for 12 weeks. Receives: Drug: HT-6184; Drug: Semaglutide 1 mg |
| HT-6184 2mg Matching Placebo | Placebo comparator | Placebo: dosed once a day, orally (PO QD) + semaglutide (1 mg): dosed weekly (q1wk), via SC injection for 12 weeks. Receives: Drug: HT-6184 Matching Placebo; Drug: Semaglutide 1 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess glycemic control using HbA1c (%)
Evaluate glycemic control using HbA1c (%) from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide. This outcome will assess if the participant was able to reduce HbA1c by at least 1.5%.
Measured: From first dose through End of Study (up to 12 weeks per participant)
Assess weight loss using body weight measurements
Evaluate weight loss using body weight measurements from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide. This outcome will assess if the participant was able to reduce body weight by at least 5%.
Measured: From first dose through End of Study (up to 12 weeks per participant)
Secondary outcomes (6)
Assess the change in HbA1c (% point)
Evaluate the change in HbA1c (% point) from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide.
Measured: From first dose through End of Study (up to 12 weeks per participant)
Assess the change in body composition utilizing DEXA body scan
Evaluate the change in body composition utilizing DEXA body scan from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide.
Measured: From first dose through End of Study (up to 12 weeks per participant)
Assess the PK profile; AUC 0-inf, AUC 0-last, AUC tau, Cmax, tmax, t1/2, and Cl/F
Evaluate the PK profile (AUC 0-inf, AUC 0-last, AUC tau, Cmax, tmax, t1/2, and Cl/F) of ofirnoflast in participants treated with ofirnoflast and semaglutide
Measured: From first dose through End of Study (up to 12 weeks per participant)
Assess number of participants who experience Serious Adverse Events (SAEs)
The safety and tolerability of ofirnoflast or placebo in combination with semaglutide will be evaluated based on the incidence of SAE in participants, as assessed according to CTCAE v5.0. The number of participants who experience a SAE will be reported.
Measured: From first dose through End of Study (up to 12 weeks per participant)
Assess number of participants who experience treatment emergent adverse events (TEAEs)
The safety and tolerability of ofirnoflast or placebo in combination with semaglutide will be evaluated based on the incidence of TEAE in participants, as assessed according to CTCAE v5.0. The number of participants who experience a TEAEs will be reported.
Measured: From first dose through End of Study (up to 12 weeks per participant)
Assess number of participants who experience treatment related adverse events (TRAEs)
The safety and tolerability of ofirnoflast or placebo in combination with semaglutide will be evaluated based on the incidence of TRAEs in participants, as assessed according to CTCAE v5.0. The number of participants who experience a TRAEs will be reported.
Measured: From first dose through End of Study (up to 12 weeks per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start6 Jan 2026
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Why it stopped: Business decision to move away from this indication with this intervention, and low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halia Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172867
- Sponsor's protocol ID
- HT-6184-IIO-001
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study to Evaluate the Safety, Efficacy and Tolerability of Ofirnoflast (HT-6184) and Semaglutide in Obese or Overweight Participants With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT07172867
- Acronym / sponsor ID
- HT-6184-IIO-001
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision to move away from this indication with this intervention, and low enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Halia Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
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 is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM.
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial.
- The study duration will be up to 28 weeks.
- The screening period will be up to 4 weeks
- The treatment duration will be 12 weeks.
- The follow-up period will be 12 weeks
- The visit frequency will be every 4 weeks during the treatment phase of the study.
- There will be an anticipated 7 scheduled clinic visits, including 1 screening visit and 2 follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HT-6184 2mg Treatment | Experimental | Drug: HT-6184, Drug: Semaglutide 1 mgOfirnoflast (2 mg): dosed once a day, orally (PO QD) + semaglutide (1 mg): dosed weekly (q1wk), via subcutaneous (SC) injection for 12 weeks. |
| HT-6184 2mg Matching Placebo | Placebo comparator | Drug: HT-6184 Matching Placebo, Drug: Semaglutide 1 mgPlacebo: dosed once a day, orally (PO QD) + semaglutide (1 mg): dosed weekly (q1wk), via SC injection for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- BMI between 27 kg/m2 and 40 kg/m2.
- Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg.
- HbA1c is 7.5-10.5% at screening.
Key exclusion criteria (27 listed)
- Any prescription or over-the-counter medications intended for weight loss within 6 months of screening, excluding semaglutide.
- History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (e.g. Ozempic® or Wegovy®)
- Use of other investigational drugs at the time of screening or within 30 days or 5 half-lives prior to signing of the ICF, whichever is longer, or longer if required by local regulations
- Previous or current diagnosis of Type 1 diabetes mellitus (T1DM) or current gestational diabetes.
- Diagnosis of T2DM requiring current use of insulin, repaglinide, saxagliptin, and sulfonylureas.
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 |
|---|---|---|
| HT-61842mg QD | Drug | HT-6184 2mg Treatment |
| HT-6184 Matching Placebo2mg QD | Drug | HT-6184 2mg Matching Placebo |
| Semaglutide 1 mgSemaglutide 1 mg, every week | Drug | HT-6184 2mg Matching Placebo, HT-6184 2mg Treatment |
Primary outcome
Assess glycemic control using HbA1c (%)
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Evaluate glycemic control using HbA1c (%) from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide. This outcome will assess if the participant was able to reduce HbA1c by at least 1.5%.
Assess weight loss using body weight measurements
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Evaluate weight loss using body weight measurements from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide. This outcome will assess if the participant was able to reduce body weight by at least 5%.
6 secondary outcomes
Assess the change in HbA1c (% point)
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess the change in body composition utilizing DEXA body scan
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess the PK profile; AUC 0-inf, AUC 0-last, AUC tau, Cmax, tmax, t1/2, and Cl/F
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess number of participants who experience Serious Adverse Events (SAEs)
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess number of participants who experience treatment emergent adverse events (TEAEs)
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess number of participants who experience treatment related adverse events (TRAEs)
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HT-6184 and Semaglutide 1 mg in people with Diabetes Mellitus, Type 2 and Obesity, run by Halia Therapeutics, Inc. at 1 site in United Arab Emirates.
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 16 inclusion and 27 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: withdrawn, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assess glycemic control using HbA1c (%) (time frame: From first dose through End of Study (up to 12 weeks per participant)). 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 25 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.